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Category:Clinical/Medical Research

FSP CRA Nivel I64960540760962120

FSP CRA Nivel I

**Horario de trabajo** Estándar (lun\-vie)**Condiciones ambientales** Oficina**Descripción del puesto** Revisar la descripción del puesto de FSP CRA Nivel I Experiencia previa que aporte los conocimientos, habilidades y capacidades necesarios para desempeñar el puesto (preferiblemente equivalente a un año).

Country Approval Specialist64840858384130121

Country Approval Specialist

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** * Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. * Provides, under guidance local regulatory strategy advice (MoH \&/or EC) to internal clients. * Provides project specific local SIA services and coordination of these projects. * May have contact with investigators for submission related activities. * Key\-contact at country level for either Ethical or Regulatory submission\-related activities. * Coordinates, under guidance, with internal functional departments to ensure various site start\-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. * Achieves PPD’s target cycle times for site. * May work with the start\-up CRA(s) to prepare the regulatory compliance review packages, as applicable. * May develop country specific Patient Information Sheet/Informed Consent form documents. * May assist with grant budgets(s) and payment schedules negotiations with sites. * Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. * Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. * Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. * Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

CRA (Level I)64748724311043122

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Monitors investigator sites with a risk\-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem\-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on\-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows\-up on findings as applicable. Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH\-GCP and applicable regulations. Conducts on\-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory equirements/audits/inspections. Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. Travel requirement higher than 75%.

SR CRA (Level I) - FSP64520863810818123

SR CRA (Level I) - FSP

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Previous experience that provides the knowledge, skills and capabilities to perform the job (comparable to 2 years preferred) In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. CRA must have adequate neurology monitoring experience. In addition, rare disease and pediatric experience is strongly advised.

Regional Specialist64329826311555124

Regional Specialist

**Job Overview** Remote Research Clinical **Regional Specialists** (RS) are an integral part of remote visit delivery, liaising with clinical teams, clinicians, and investigator sites for remote visits. The RS works in partnership with the RRC Lead providing support with remote visit activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s. **Essential Functions** Site and Nurse Onboarding * Conduct outreach and training for investigator sites opting into RRC services. * Train and onboard research clinicians, ensuring they are prepared and study\-ready. * Manage access to systems like Study Hub and Thinking Cap for both site staff and clinicians. Remote Visit Coordination * Receive and process Visit Request Forms (VRFs). * Assign and confirm clinicians for remote visits. * Coordinate visit logistics including supplies, equipment, and courier services. * Ensure all required documentation (e.g., DOA logs, nurse credentials) is complete and uploaded. Document and Data Management * Maintain and update Smartsheet trackers for sites, visits, and nurses. * Perform quality checks on source documents and ensure timely corrections. * Review uploaded documents in Study Hub and notify relevant stakeholders. Training and Compliance * Deliver study\-specific training to sites and clinicians. * Ensure compliance with GCP, ICH, HIPAA, and IQVIA SOPs. Communication and Support * Serve as the primary liaison between sites, nurses, and internal study teams. * Provide ongoing support and retraining to nurses as needed. * Escalate issues to RNPS Lead and ensure resolution. Courier and Logistics Management * Book and track courier shipments for study drug, samples, and documents. * Manage inventory and supply needs for nurses and depots. **Requirements** * Bachelor's Degree Life sciences or other related field * Typically requires 0 \- 2 years of prior relevant experience on **site management** (Site Coordinator experience or CRA experience) \- with visit coordinator skills or relevant project management experience * Advanced level of **English** is a must * Ideally based in Brazil, but also open to Argentina \#LI\-NRJ \#LI\-Remote IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

FSP CRA Level I64329826326786125

FSP CRA Level I

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Review Job Description FSP CRA Level I Previous experience that provides the knowledge, skills and capabilities to perform the job (comparable to one year preferred).

Clinical Trial Manager II (CTM II), Dermatology & Rheumatology, Argentina64329826342273126

Clinical Trial Manager II (CTM II), Dermatology & Rheumatology, Argentina

The **Clinical Trial Manager II (CTM II), Dermatology \& Rheumatology,** is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables of clinical trials. This includes but is not limited to clinical research associate (CRA) training, identification of quality issues related to site performance and clinical monitoring activities, establishing action plans to address any concerns, as well as ensuring timelines are met. **This role will be perfect for you if**: * You enjoy working with a mid\-sized CRO where you can build professional relationships with your colleagues at all levels * You bring previous experience in managing the clinical monitoring portion of clinical projects * Dermatology and rheumatology are therapeutic areas you enjoy or want to learn more about **RESPONSIBILITIES** * Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study\-specific requirements; * Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow\-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions; * Serves as a point of contact for CRAs and Lead CRAs for assigned projects; * Provides mentoring/oversight of CRAs and Lead CRAs; * Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance; * Contributes to the development of the Clinical Monitoring Plan; * Prepares and conducts project\-specific training for the CRAs; * Develops the annotated site visit reports and monitoring tools such as source data verification worksheets; * Conducts quality control visits with CRAs; * Coordinates and leads CRA meetings; * Performs co\-monitoring visits with CRAs; * May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)). Requirements: **IDEAL PROFILE** **Education** * B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience; **Experience** * At least 8 years of clinical research experience including prior monitoring experience and at least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry; **Knowledge and skills** * Strong knowledge of ICH/GCP standards and applicable regulatory requirements; * Excellent mastery of Microsoft Office suite (Word, Excel, Power Point); * Ability to work in a fast\-paced evolving environment and establish good relationships with colleagues, sites and sponsors; * Excellent leadership, organizational, time management and multi\-tasking skills; * Excellent judgement and problem\-solving skills; * Occasional travel (up to 10% of the time), including some travel outside of the country once possible; * Fluent in English (excellent oral and written); * Experience in a CRO and in dermatology an asset. Our company: **The work environment** At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: * Flexible work schedule / work schedule : * Home\-based position * Ongoing learning and development **About Indero** **Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.** ***Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.*** ***Indero only accepts applicants who can legally work in Argentina.*** Brand name: Indero

Site Engagement Liaison64329826357763127

Site Engagement Liaison

**Overview** ------------ As a **Site Engagement Liaison** you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions. **Responsibilities** -------------------- **What you will be doing:** A **Site Engagement Liaison** is a single service project manager for clinical operations.* Manages and prioritizes the clinical deliverables to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations. * Creates and administers clinical and site training plans. Ensures clinical team understands responsibilities and performance standards. * Recognizes potential risks within the study protocol and operational aspects of the trial; proactively establishes contingency and mitigation plans. * Ensures that quality standards and applicable regulatory requirements are met. Facilitates internal audits and local health authority inspections as needed. * Communicates effectively with sponsor, project manager, functional team leads and other project team members. Leads clinical study team meetings. * Provides training and guidance to clinical study team members. **Qualifications** ------------------ **You are:*** Bachelor’s degree in a health, life sciences or other relevant field of study. * 5 years of relevant experience in Clinical Operations related roles \- onsite primary Lead CRA experience is high valued. * Occasional travel as needed. * Open to go to the office at least twice per week. * All employees must read, write and speak fluent English and host country language. * Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. **What ICON can offer you:** Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well\-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family’s needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24\-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well\-being * Life assurance * Flexible country\-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion \& belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable\-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

2222+22 General Levalle, Córdoba, Argentina

CRA64180334639491128

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Monitors investigator sites with a risk\-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem\-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on\-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows\-up on findings as applicable. Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH\-GCP and applicable regulations. Conducts on\-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory equirements/audits/inspections. Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. Travel requirement higher than 75%.

CRA II or Senior CRA - Buenos Aires (FSP - Sponsor Dedicated)64142368021251129

CRA II or Senior CRA - Buenos Aires (FSP - Sponsor Dedicated)

CRA II or Senior CRA \- Buenos Aires (FSP \- Sponsor Dedicated) ICON plc is a world\-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate II or Senior to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing* Conducting site qualification, initiation, monitoring, and close\-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high\-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile* Bachelor's degree in a scientific or healthcare\-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In\-depth knowledge of clinical trial processes, regulations, and ICH\-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast\-paced environment. * Ability to travel at least 60% of the time (international and domestic \- fly and drive) and should possess a valid driver’s license What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well\-being and work life balance opportunities for you and your family. Our benefits examples include:* Various annual leave entitlements * A range of health insurance offerings to suit you and your family’s needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, TELUS Health, offering 24\-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well\-being. * Life assurance * Flexible country\-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion \& belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

CRA II (Multi-sponsor) - Argentina Home Based641423680427531210

CRA II (Multi-sponsor) - Argentina Home Based

**Description** CRA II (Multi\-sponsor) \- Argentina Home Based Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full\-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: **WORK HERE MATTERS EVERYWHERE** Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. **Job Responsibilities** * Conduct on\-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms * Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates * Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials * Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues * Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow\-up letters, and action plans * Collaborate with cross\-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct **Qualifications:** * Bachelor's degree in a related field or equivalent experience * Minimum of 2\-4 years of experience in clinical research monitoring * Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements * Excellent communication and interpersonal skills * Ability to work independently and manage multiple priorities * Proficiency in using clinical trial management systems and other relevant software **Certifications:** * Certified Clinical Research Associate (CCRA) or equivalent certification preferred **Necessary Skills:** * Attention to detail and strong analytical skills * Problem\-solving abilities and critical thinking * Ability to work effectively in a team environment * Strong organizational and time management skills * Proficiency in Microsoft Office Suite \#LI\-SA2 **Get to know Syneos Health** Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000\+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever\-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com **Additional Information** Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. **Summary** Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes conducting on\-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA job family at the P21 level have a significant impact on the quality and integrity of clinical research studies. By ensuring adherence to clinical practices and protocols, these roles contribute to the reliability and validity of study results. They play a crucial role in the development and implementation of monitoring tools and procedures, which enhance the overall efficiency and effectiveness of clinical trials. Their contributions are essential for advancing medical knowledge and improving patient outcomes.Core Focus•Conduct thorough on\-site and remote monitoring of clinical research studies•Develop and implement tools, procedures, and processes to ensure quality monitoring•Manage defined components of projects or processes within their area of responsibility•Utilize practical knowledge of a professional area, typically obtained through education combined with experience•Maintain high standards of clinical practice and ensure the success of clinical trials

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Patient Safety Specialist641423679983381211

Patient Safety Specialist

### **Summary** Monitor and audit the company's drug, biological product, or medical device surveillance program, including intake, evaluation, processing, and follow-up of adverse event reports. Participate in addressing any legal liability and compliance with government regulations. Ensure accurate receipt, maintenance, and evaluation regarding product labeling. Report required events or reactions to regulatory agencies, including adverse event data from clinical trials, spontaneous or solicited sources, periodic reports, and experience. May provide detection and assessment of safety trends and signals. Support all clinical trial and post-marketing activities. ### **About the Role** Major Accountabilities \~ Support management of operational processes to ensure compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of marketed and investigational Novartis products \~ Manage collection, processing, documentation, reporting, and follow-up of all adverse event (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), patient-focused programs (PFP), registries, and all spontaneous reports (SR). \~ Accurately and systematically transcribe, translate (if needed), and enter data from all serious adverse events (from clinical trials) and all adverse events (from PFP, PMS, registries, and all REPORTS) from source documents into safety systems, emphasizing speed and quality. \~ Record and track receipt, submissions, and distribution of documents such as SUSARs, SRs, investigator notifications, etc., in collaboration with other departments \~ Manage reporting/submission/distribution of safety reports/updates/information to local health authorities and/or clinical operations in collaboration with other departments. \~ Work with other local/global PV associates to ensure accurate assessment of safety data. \~ Interact and exchange relevant safety information with LHA, PV associates, other functional groups, and third-party contractors as applicable. \~ Investigate and monitor global/regional/national (as applicable) pharmacovigilance regulations and provide updates to the global PV organization. \~ Develop, update, and implement local procedures to ensure compliance with global procedures and national PV requirements. \~ Management and maintenance of all relevant PV databases as applicable. \~ Develop and update training materials for pharmacovigilance \~ Provide support and closure for audits, corrective action plan activities, and health authority inspections. \~ Provide timely relevant information to trial coordinators, CRAs, and other Novartis employees \~ Distribution of commercial samples (if applicable) Key Performance Indicators Monitor and audit the company's drug, biological product, or medical device surveillance program, including intake, evaluation, processing, and follow-up of adverse event reports. Participate in addressing any legal liability and compliance with government regulations. Ensure accurate receipt, maintenance, and evaluation regarding product labeling. Report required events or reactions to regulatory agencies, including adverse event data from clinical trials, spontaneous or solicited sources, periodic reports, and experience. May provide detection and assessment of safety trends and signals. Support all clinical trial and post-marketing activities. Work Experience \~ Management and execution of operations \~ Cross-border collaboration \~ Functional scope Skills \~ Document submission \~ Pharmacovigilance \~ Safety science \~ Fundamentals \~ Employee training \~ Reporting Language English **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture **Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network **Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits\-rewards Division Development Business Unit Innovative Medicines Location Argentina Site Ramallo (Argentina) Company / Legal Entity AR01 (FCRS \= AR001\) Novartis Argentina S.A. Functional Area Research \& Development Job Type Part time Employment Type CDI Shift Work No

GXCH+HM Ramallo, Buenos Aires Province, Argentina

Clinical Research Associate I641423679591701212

Clinical Research Associate I

**Company Description** PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on\-time services across a variety of therapeutic indications. **Job Description** Hybrid position in Buenos Aires Only CV's in English will be considered We are looking for a CRA to join our team in Argentina. Here you will have the opportunity to develop yourself as a senior, trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring. Responsibilities will include: * Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits * Delivering training of investigators, site staff and project teams * Work with complex studies * Perform CRF review, source document verification and query resolution * Be responsible for site communication and management * Be involved in site identification process * Contact for clinical investigators, vendors and support services in regard to study progress * Participate in feasibility research * Preparation and delivering of presentations at Investigator’s Meetings * Preparation for and attendance at company’s audits; resolution of audit findings * Support to Regulatory Affairs in procurement of site regulatory documents * Maintenance of study\-specific automated tracking systems **Qualifications** * Bachelor's degree in Medicine * At least 2 years experience in patient care and/or health care or clinical environment * Full working proficiency in Spanish and English * Experience in Clinical Research is a plus * Availability to travel * Proficiency in MS Office applications * Ability to plan and work in a dynamic team environment * Communication, collaboration, and problem\-solving skills **Additional Information** Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Clinical Research Associate II641423679787541213

Clinical Research Associate II

**Company Description** PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on\-time services across a variety of therapeutic indications. **Job Description** **If you are currently a CRA I looking forward to the next step of your career, this might be the right position for you!** As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will: * Conduct and report all types of onsite monitoring visits * Be involved in study startup and feasibility research * Perform CRF review, source document verification and query resolution * Be responsible for site communication and management * Be a point of contact for in\-house support services and vendors * Communicate with internal project teams regarding study progress * Support regulatory team in preparing documents for study submissions **Qualifications** * College/University degree in Life Sciences or an equivalent combination of education, training \& experience * 1 \- 2 years of independent on\-site monitoring experience in Argentina * Experience in all types of monitoring visits in Phase II / III * Full working proficiency in English and Spanish * Proficiency in MS Office applications * Ability to plan and work in a dynamic team environment * Communication, collaboration, and problem\-solving skills * Ability to travel **Additional Information** This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Safety Specialist II - HYBRID - ARG641423674981141214

Safety Specialist II - HYBRID - ARG

**Description** Safety Specialist II \- HYBRID \- ARG Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full\-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: **WORK HERE MATTERS EVERYWHERE** Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. **Job Responsibilities** * Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required. * May assist in the preparation of the project plans such as Safety Management Plan. * May perform set\-up, delivery and close\-out of safety and pharmacovigilance projects. * Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program\-specific safety plans. * Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. * Enters data into safety database. * Codes events, medical history, concomitant medications, and tests. * Compiles complete narrative summaries. * Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. * Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. * Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. * Maintains safety tracking for assigned activities. * Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required. * Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. * Manual recoding of un\-recoded product and substance terms arises from ICSRs. * Identification and management of duplicate ICSRs. * Activities related to SPOR / IDMP. * Quality review of ICSRs. * Quality review for the work performed by peers. * Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries; mentoring, coaching, and training of new hires. * Fosters constructive and professional working relationships with all project team members, internal and external. * Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. * Ensures distribution of all required individual expedited and periodic reports for both clinical and post\-marketing projects to the Safety Submissions team if contracted to submit the reports. * Participate in audits/inspections as required. * Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post\-marketing programs as appropriate. * Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. **Get to know Syneos Health** Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000\+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever\-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com **Additional Information** Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. **Summary** Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ISCR reports, management of duplicate ICSR cases, Quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) activities)) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program\-specific procedures for clinical trials and/or post\-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

CRA1638367832423691215

Whether you’re beginning or continuing your career as a CRA, this role is an ideal stepping\-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award winning and innovative, we’ll give you access to cutting\-edge in\-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You’ll be building a smart and flexible career with no limits. **While projects vary, your typical responsibilities might include:** * Performing site selection, initiation, monitoring and close\-out visits, plus maintaining appropriate documentation * Supporting the development of a subject recruitment plan * Establishing regular lines of communication plus administering protocol and related study training to assigned sites * Evaluating the quality and integrity of site practices – escalating quality issues as appropriate * Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements. **You should have:** * A Bachelor's degree in a health care or other scientific discipline or educational equivalent * At least 2 years of remote monitoring experience or as Study Coordinator. * Advanced in English. * Travel availability (50%) * Alternatively, you should have an equivalent combination of education, training and experience If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Referral Specialist638367832628511216

Referral Specialist

**Company Description** We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **Job Description** Hybrid work agreement \- office in Buenos Aires Only CV's in English will be considered Are you an experienced **Clinical Research Professional** looking for new development opportunities? This might be a great opportunity for you! We have an exciting opening for a Referral Network Specialist, which is a dynamic role designed to take your career to the next level. Use your expertise, broaden your professional scope, and contribute to the growth of PSI's innovative referral programs. In this exciting role, you will build and manage a country\-specific network of referring physicians across various therapeutic areas. You will play a key role in ensuring a smooth and effective referral process between referring physicians and study investigators. **You will have the opportunity to:** * Identify and select physicians, providing them with valuable training and support throughout the referral process to enhance their skills and effectiveness. * Plan and conduct regular visits to referring physicians, whether in person and/or via video conference, to promote collaboration. Following this, you will be responsible for documenting key discussions and objectives in a report. * Provide ongoing support to referring physicians and their teams, ensuring agreed\-upon tasks are executed accurately and efficiently. * Collaborate with various departments at PSI CRO, including Clinical Operations, Regulatory, and Legal, to ensure the successful implementation of the referral process across all projects. **Qualifications** * College/University degree in Life Sciences or an equivalent combination of education, training \& experience * Minimum 3 years of clinical research experience * Prior experience in communication with Key Opinion Leaders as CRA/Senior CRA * Experience communicating with physicians and/or investigators required * Oncology and Gastroenterology experience is a plus * Availability to travel * Ability to work both independently and in a team environment * PC skills to be able to work with MS Word, Excel and PowerPoint **Additional Information** If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. You will be a part of an established global Referral team with excellent growth opportunities.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Data Manager / Study Coordinator638367832746251217

Data Manager / Study Coordinator

**Job Offer Details** ------------------------- Publication Date Status \- Internal Reference: 015/2025 Conditions \- Work Center: IMIBIC, Av. Menéndez Pidal s/n, 14004 Córdoba, Spain. * Number of positions available: 1 * Professional group: Technician. * Position funding source: Research group fund. * Contract funded by European funds: No Minimum Requirements \- University degree in Life Sciences. Desirable \- Accredited level of English, minimum B2 Responsibilities \- Follow-up of patients included in the project's studies and clinical trials. * Monitoring of patients' clinical, laboratory, and epidemiological data. Applications must include a CV and scanned documentation proving that minimum requirements are met. In the CV, it is essential to specify the duration in months of any experience or merits subject to evaluation. This job posting will be published on FIBICO notice boards, as well as on the following websites: \- On the IMIBIC website (/\>\- On the Reina Sofía University Hospital website In the email, it is essential to indicate the call reference in the subject line along with the NIF or NIE number. Applications without the reference and NIF or NIE number will not be considered. Deadline: Day Year Start Date End Date \#J\-18808\-Ljbffr**Nominal Salary****:** To be determined **Source****:** Jobleads

José Antonio de Sucre 1409, X5000JXH Córdoba, Argentina

Site Management Associate I638367831029791218

Site Management Associate I

**Company Description** We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **Job Description** Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents \& information. **Only CVs in English will be accepted.** **You will be responsible for:** * Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion. * Serves as the primary sites’ contact point for vendors, study supplies, and * access management. * Ensure that pre\-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed * Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS. * Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies. * Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions. * Coordinate preparation for and follow\-up on site, TMF and systems´ audits and inspections. * Manage the TMF on a site and a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists. * Arrange and track initial and on\-going project training for site teams in all vendor\-related systems. * Document Management and translations status review of the study. * Ensures proper safety information flow with investigative sites. **Qualifications** * College/University Degree in Life Sciences; * Administrative work experience, preferably in an international settings; * Prior experience working as CTA for CROs; * Prior experience working in Clinical Research; * Local regulations knowledge; * Full working proficiency in English and Spanish; * Proficiency in MS Office applications; * Ability to plan and work in a dynamic team environment; * Communication and collaboration skills. **Additional Information** Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

CRA2 - Homebased638367831370251219

CRA2 - Homebased

**CRA 2 \- Homebased** This role is an ideal stepping\-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award winning and innovative, we’ll give you access to cutting\-edge in\-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You’ll be building a smart and flexible career with no limits. While projects vary, your typical responsibilities might include: * Performing site selection, initiation, monitoring and close\-out visits, plus maintaining appropriate documentation * Supporting the development of a subject recruitment plan * Establishing regular lines of communication plus administering protocol and related study training to assigned sites * Evaluating the quality and integrity of site practices – escalating quality issues as appropriate * Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution * You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements. **REQUIREMENTS** You should have: * A Bachelor's degree in a health care or other scientific discipline or educational equivalent * At least 2 years of on\-site monitoring experience (Mandatory) * Advanced in English. * Availability to travel (50% of time) * Located in Buenos Aires, Argentina. * *Alternatively, you should have an equivalent combination of education, training and experience* If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Senior CRA638367831541771220

The Senior Clinical Research Associate (CRA) will play a crucial role in the planning, execution, and management of clinical trials. This position requires a highly skilled and experienced professional who can ensure the integrity of clinical data, compliance with regulatory requirements, and the overall success of clinical research projects. While projects vary, your typical responsibilities might include: * Performing site selection, initiation, monitoring and close\-out visits, plus maintaining appropriate documentation * Supporting the development of a subject recruitment plan * Establishing regular lines of communication plus administering protocol and related study training to assigned sites * Evaluating the quality and integrity of site practices – escalating quality issues as appropriate * Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution * You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements. **REQUIREMENTS** You should have: * A Bachelor's degree in a health care or other scientific discipline or educational equivalent * At least 4 years of on\-site monitoring experience. * Advanced in English. * In\-depth knowledge of GCP, ICH guidelines, and regulatory requirements. * Strong organizational and time management skills. * Excellent communication and interpersonal skills. * Ability to work independently and as part of a team. * Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems. * Willingness to travel as required. If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

CRA II & Senior CRA (Argentina)638367831719711221

CRA II & Senior CRA (Argentina)

CRA I \& CRA II (Argentina) ICON plc is a world\-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking CRAs II \& Senior CRAs to join our diverse and dynamic team at ICON Plc. As a key member of our research department, you will be responsible for overseeing and coordinating clinical trials, ensuring compliance with regulations, and collecting and analyzing critical data. What you will be doing:* Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation * Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. * Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. * Ensure patient safety by ensuring compliance with ICON’s procedures, protocols, and regulatory requirements. Your profile:* University degree in medicine, science, or equivalent * Experience monitoring on site \+18 months (CRA II) or \+24 months (Senior CRA). * Knowledge of ICH\-GCP guidelines and the expertise to review and evaluate medical data * Excellent written and verbal communication in English * Good social skills enabling you to deal with queries in a timely manner * Ability to travel at least 60% of the time (international and domestic \- fly and drive) and should possess a valid drivers license \#LI\-FP1 \#LI\-Remote What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well\-being and work life balance opportunities for you and your family. Our benefits examples include:* Various annual leave entitlements * A range of health insurance offerings to suit you and your family’s needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, TELUS Health, offering 24\-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well\-being. * Life assurance * Flexible country\-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion \& belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Senior Clinical Research Associate638367831910411222

Senior Clinical Research Associate

**Company Description** We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **Job Description** We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring. Responsibilities will include: * Training, mentoring and supervising study level responsibilities for Jr. CRAs * Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits * Delivering training of investigators, site staff and project teams * Work with complex studies * Perform CRF review, source document verification and query resolution * Be responsible for site communication and management * Be involved in site identification process * Contact for clinical investigators, vendors and support services in regard to study progress * Participate in feasibility research * Preparation and delivering of presentations at Investigator’s Meetings * Preparation for and attendance at company’s audits; resolution of audit findings * Support to Regulatory Affairs in procurement of site regulatory documents * Maintenance of study\-specific automated tracking systems **Qualifications** * College/University degree in Life Sciences or an equivalent combination of education, training \& experience * Full working proficiency in Spanish and English * At least 3 years of independent on\-site monitoring experience in Argentina * Experience in all types of monitoring visits in Phase II and/or III * Availability to travel * Experience in Oncology or Infectious Diseases is a plus * Proficiency in MS Office applications * Ability to plan and work in a dynamic team environment * Communication, collaboration, and problem\-solving skills **Additional Information** If you like to train and support others on their clinical research steps, and are also looking forward to future Lead Monitor roles, this position may just be the right one for you. Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Site Contract Manager - CRO638367829809931223

Site Contract Manager - CRO

Job Summary : Join Medpace at our Buenos Aires office! Our clinical operations activities are growing rapidly, and we are currently seeking a full\-time, Site Contract Manager to join our LatAm Site Contracts team within the Clinical Operations department. This position will report to the LatAm Senior Contract Manager and will play a key role in the study start\-up and clinical trial management processes at Medpace. The Contract Manager will play a key role in advancing the start\-up of our projects. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities : * Act as Contract Study Lead on allocated studies with active responsibility for the performance of the contract team assigned to the study, acting as a primary point of contact between Sponsor and study teams, determining site contract processes, delegating duties to staff, and providing functional oversight of site contract and budget negotiations; * Create project\-specific site contract documents, including study templates; * Review contract queries that fall outside of agreed parameters escalated by Contract Specialists; * Ensure Contract staff provide timely and accurate budget and contract review and execution, as well as meaningful updates in ClinTrak; * Facilitate clear communication, evaluation, and reporting of ongoing contract negotiations to study teams (e.g., Clinical Trial Management, Regulatory Submissions), ensuring that timelines are met, delays are managed effectively, and study team and Sponsor concerns are addressed as appropriate; * Provide contract support and advice related to site payments, site contracts, and other related documents and vendor contracts, identifying potential contractual issues, addressing, escalating and/or resolving such in order to minimize contractual risk to the organization; * Support in the development and implementation of contract management and compliance initiatives; * Line manage local or remote staff where applicable, including recruitment, training and development, and functional oversight of staff; and * May be responsible for other projects and responsibilities as assigned. Qualifications : * Bachelor’s degree, preferably in the area of Business, Life Sciences, or Law, with 4 years of clinical research industry experience, in clinical operations with contract management experience, or Juris Doctorate/Advanced education in the field of law and 2 years of clinical research industry experience with contract management experience; * Experience with LATAM Site Contracts required; US project experience preferred; * Broad knowledge of clinical trial conduct, standards of Good Clinical Practice, and applicable regulations and laws; * Demonstrated knowledge and ability to review and revise contracts for legal implications; and * Demonstrated ability to successfully motivate and collaborate with internal and external study team members, including Contract Specialists without direct reporting relationship. * Fluency in English **\*\*\*We kindly ask to submit CV in English** Medpace Overview : Medpace is a full\-service clinical contract research organization (CRO). We provide Phase I\-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti\-viral and anti\-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40\+ countries. Why Medpace? : When you join Medpace, you become part of a team dedicated to supporting the development of ground\-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities. **Organic Growth:**Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO. **Perks (*****vary by location and position*****):*** On\-site fitness center(s) * Campus walking paths * Company\-sponsored social and wellness events * Official Sponsor of FC Cincinnati * Hybrid work\-from\-home options and flexible work schedule * On\-site Market Place * Free and covered parking * Discounts for local businesses * On campus restaurants and banks coming soon **Awards:*** Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer * Recognized by Forbes as one of America's Best Mid\-size Companies in 2021 * Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation \& organization, accessibility of staff, open communication, and ensuring timely drug availability * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility * Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati **What to Expect Next:** A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview. *EO/AA Employer M/F/Disability/Vets*

Av. Juramento 1777, C1428 Cdad. Autónoma de Buenos Aires, Argentina

Clinical Research Associate638367829916171224

Clinical Research Associate

**Detalles de la oferta** ------------------------- CliniRx have a number of CRA positions available to support a global study in Q1 2025\. We are expanding at a rapid rate and have multiple opportunities on a permanent basis to join us on a global study. Ideally you will come from a CRO background with experience across multiple therapeutic area's. As a global contract research organization (CRO), we offer a diverse slate of clinical development and resource solutions reflecting both full\-service CRO and functional service provider (FSP) models. In supporting clinical outsourcing needs for emerging biotech and pharmaceutical companies—most notably small to mid\-size enterprises facing unique challenges we offer our expertise with a presence in key markets including the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia Primary Purpose : We are seeking skilled CRA's to ensure the timely and qualitative delivery of site monitoring activities in alignment with our Site Monitoring Plan (SMP). Key Responsibilities : Deliver on the Site Monitoring Plan : Gain a comprehensive understanding of the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality and timelines.Site Management Compliance : Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.Site Identification : Assist in identifying new potential sites within various therapeutic areas to expand our clinical network.Continuous Skill Development : Regularly enhance both technical and soft skills, applying them to elevate performance and project outcomes.Work Relations : Report to the Manager of Clinical Operations for project, functional, and administrative matters.Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative executives.Value Added : Your adherence to the quality and timelines of the monitoring plan will be crucial for the efficient delivery of our projects and overall success. Key Success Factors : Timely and high\-quality execution of site monitoring activities.Prompt report generation and submission to stakeholders.Essential Skills Experience : Education : Bachelor's or Master's degree in a scientific discipline.Experience : 1\-4 years of experience in site monitoring within clinical research.Skills : Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication; ability to multitask and thrive under demanding timelines. \#J\-18808\-Ljbffr **Salario Nominal****:** A convenir **Fuente****:** Jobleads

Machado 162, B7000 Tandil, Provincia de Buenos Aires, Argentina

Senior Cra / Cra Ii638367830241311225

Senior Cra / Cra Ii

**Detalles de la oferta** ------------------------- Senior CRA / CRA II ICON plc is a world\-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate (CRA) or CRA II to join our diverse and dynamic team. As a Senior CRA/ CRA II at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. What You Will Be Doing: Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.Collaborating with cross\-functional teams to ensure timely and accurate data collection and reporting.Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.Your Profile: Advanced degree in a relevant field such as life sciences, nursing, or medicine.Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.Minimum of 12 months of independent monitoring experienceProven ability to manage multiple sites and projects simultaneously, with strong organizational and problem\-solving skills.Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well\-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlementsA range of health insurance offerings to suit you and your family's needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, LifeWorks, offering 24\-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well\-being.Life assuranceFlexible country\-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion \& belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply \#J\-18808\-Ljbffr **Salario Nominal****:** A convenir **Fuente****:** Jobleads

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Cra2 - Homebased638367830350091226

Cra2 - Homebased

**Detalles de la oferta** ------------------------- Join or sign in to find your next jobJoin to apply for the CRA2 \- Homebased role at IQVIA. CRA 2 \- Homebased This role is an ideal stepping\-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion, and bonus awards. As an award\-winning and innovative company, we'll give you access to cutting\-edge in\-house technology, allowing you to work on global projects with a regional/home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits. While projects vary, your typical responsibilities might include: Performing site selection, initiation, monitoring, and close\-out visits, plus maintaining appropriate documentationSupporting the development of a subject recruitment planEstablishing regular communication and administering protocol and related study training to assigned sitesEvaluating the quality and integrity of site practices – escalating quality issues as appropriateManaging progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolutionCollaborating and communicating effectively with colleagues and customers. A good basic knowledge of applicable clinical research regulatory requirements is preferred.RequirementsA Bachelor's degree in a healthcare or other scientific discipline or equivalent educationAt least 2 years of on\-site monitoring experience (Mandatory)Proficiency in EnglishAvailability to travel approximately 50% of the timeLocated in Buenos Aires, ArgentinaAlternatively, an equivalent combination of education, training, and experienceIf you want to make an impact in the global research market and help improve patient health, we encourage you to apply now and join our team. IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments worldwide. Learn more at \> \#J\-18808\-Ljbffr **Salario Nominal****:** A convenir **Fuente****:** Jobleads

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Central Monitor in LATAM638367830528011227

Central Monitor in LATAM

**Job Overview** A Central Monitor is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. Provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts. **Essential Functions:** * Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs, respective regulations and guideline. * Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information. * Perform Management of triggers and preparation of i\-site pack for respective sites and countries for assigned study(ies). * May assist in developing required basic data analytics scope and performing the trend analytics for their respective study(ies). * Participate on study team meetings and interact with cross functional staff to verify information and/or triage new data issues or prior identified action items. * Escalate quality issues pertaining to site to respective Centralized Monitoring Lead/ Sr. Central Monitor. * May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion \& exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review. * Interaction with sites/CRA and follow\-up on study required milestones from the project start until close out. * May act as backup/ perform the activities as per the task list delegated by Central Monitor Expert/Centralized Monitoring Lead. **Qualifications:** * Bachelor's degree in life sciences or related field, or nursing qualification; or be near to obtain the degree. * \+2 years of relevant monitoring experience (on site or remote). * Advanced level of Excel. * We are looking for someone with advanced level of **English.** This is a **home based** position. \#LI\-Remote \#LI\-NRJ IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

CRA II with at least 1 year and 6 months of monitoring experience - Sponsor dedicated - Argentina Home Based638367830864671228

CRA II with at least 1 year and 6 months of monitoring experience - Sponsor dedicated - Argentina Home Based

**Description** CRA II with at least 1 year and 6 months of monitoring experience \- Sponsor dedicated \- Argentina Home Based Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full\-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: **WORK HERE MATTERS EVERYWHERE** Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. **Job Responsibilities** * Conduct on\-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms * Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates * Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials * Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues * Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow\-up letters, and action plans * Collaborate with cross\-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct **Qualifications:** * Bachelor's degree in a related field or equivalent experience * Minimum of 2\-4 years of experience in clinical research monitoring * Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements * Excellent communication and interpersonal skills * Ability to work independently and manage multiple priorities * Proficiency in using clinical trial management systems and other relevant software **Certifications:** * Certified Clinical Research Associate (CCRA) or equivalent certification preferred **Necessary Skills:** * Attention to detail and strong analytical skills * Problem\-solving abilities and critical thinking * Ability to work effectively in a team environment * Strong organizational and time management skills * Proficiency in Microsoft Office Suite \#LI\-SA2 **Get to know Syneos Health** Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000\+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever\-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com **Additional Information** Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. **Summary** Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes conducting on\-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA job family at the P21 level have a significant impact on the quality and integrity of clinical research studies. By ensuring adherence to clinical practices and protocols, these roles contribute to the reliability and validity of study results. They play a crucial role in the development and implementation of monitoring tools and procedures, which enhance the overall efficiency and effectiveness of clinical trials. Their contributions are essential for advancing medical knowledge and improving patient outcomes.Core Focus•Conduct thorough on\-site and remote monitoring of clinical research studies•Develop and implement tools, procedures, and processes to ensure quality monitoring•Manage defined components of projects or processes within their area of responsibility•Utilize practical knowledge of a professional area, typically obtained through education combined with experience•Maintain high standards of clinical practice and ensure the success of clinical trials

Pje. Centenario 130, C1405 Cdad. Autónoma de Buenos Aires, Argentina

Clinical Research Associate-Freelance638367828564491229

Clinical Research Associate-Freelance

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a **Clinical Research Associate** to join our **Monitoring Resource** team. Reporting to the **CRA Line Manager,** this position will be a remote full\-time freelance position based in Argentina**.** **Responsibilities:*** Performing data verification of source documents; * Conducting site visits, including pre\-study, initiation, monitoring, and termination; * Confirming adherence to all FDA, ICH\-GCP, and local regulations; * Ensuring implementation and compliance with FDA, and ICH\-GCP guidelines * Participating in budget negotiation and follow\-up where applicable * Assisting with data validation and query resolution * Mentoring junior team members as required * Ensuring the completion and collection of regulatory documents **Qualifications:*** A minimum of 2 years of monitoring experience in oncology trials * Experience monitoring in early\-phase trials will be valued. * Completion of a science\-related Bachelor’s degree * Excellent knowledge of medical terminology and clinical monitoring process * Strong ICH\-GCPs knowledge * Experience with clinical trial information systems * Ability to travel up to 60% on average * Bilingualism (English/Spanish) is required Prior to applying please review TRIO's Applicant Information Notice **Teamwork · Passion · Integrity · Innovation** By4KkC0PKk

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