Summary: The freelance Clinical Research Associate (CRA) manages and monitors clinical trial sites, ensuring studies follow protocol, GCP, ICH guidelines, and regulatory requirements. Highlights: 1. Manage and monitor clinical trial sites according to protocol and GCP. 2. Join a team that values collaboration, quality, and making a difference. 3. Support study sites through initiation, monitoring, and close out activities. ### **About this role** TFS HealthScience is a leading global mid size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service Provider (FSP) solutions. The freelance Clinical Research Associate (CRA) is responsible for managing and monitoring clinical trial sites to ensure studies are conducted in accordance with protocol, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. The CRA will support study sites throughout the clinical trial lifecycle including initiation, monitoring, and close out activities. As part of our SRS team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area. ### **Key Responsibilities** * Conduct on site and remote monitoring visits including site initiation, routine monitoring, and close out visits * Ensure clinical trials are conducted according to protocol, GCP, ICH guidelines, and applicable regulatory requirements * Review source documentation and Case Report Forms (CRFs) to ensure accuracy, completeness, and data integrity * Ensure the safety and rights of study participants through proper informed consent procedures and protocol compliance * Verify proper management, storage, and accountability of Investigational Products * Prepare and submit monitoring visit reports and follow up on identified issues and action items with study sites * Maintain study documentation including Investigator Site Files and ensure timely submission to eTMF * Update CTMS and other project systems with accurate site level information * Support audit and inspection readiness activities when required ### **Qualifications** * Bachelor’s degree in Life Sciences, Nursing, or a related field or equivalent experience * At least 1 year of clinical research experience as a CRA, CTA, or similar role * Good understanding of GCP, ICH guidelines, and clinical trial processes * Experience with on site or remote monitoring activities is preferred * Strong attention to detail and organizational skills * Ability to work independently and within a cross functional team environment * Strong communication and problem solving skills * Fluent in English ### **What We Offer** We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference. ### **A Bit More About Us** Our journey began over 30 years ago in Sweden, in the city of Lund. As a full service global CRO, we build solution driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.