Senior Clinical Research Associate - Freelance
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 (FSP) solutions. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area. Please keep in mind that this is a part-time freelance short-term oppportunity (0.5 FTE)
Key Responsibilities
Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard. Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality. Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations. Review CRFs (electronic or paper) and subject source documentation for validity and accuracy. Verify proper management and accountability of Investigational Product. Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate. Monitoring Close-out visits in Ukraine.
Qualifications
Bachelor’s Degree, preferably in life science or nursing; or equivalent. Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities. Possess the understanding of Good Clinical Practice regulations, ICH guidelines. Fluent in English and Ukrainian.
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.