Archer Research is a young, dynamic, and fast-growing Contract Research Organization (CRO) based in Bioville, Diepenbeek — a vibrant hub for health innovation. We support clinical studies with medical devices across Europe and are currently looking for a Clinical Research Associate (CRA) to strengthen our team.
Your RoleAs a CRA, you will be responsible for setting up, managing, and monitoring clinical studies in accordance with regulatory requirements and Good Clinical Practice (GCP). You act as the primary point of contact for study teams and ensure the quality and integrity of study data.
Key ResponsibilitiesPreparing and following up on submissions to ethics committees and/or national authorities in European member states.Selecting potential investigators and sites, including assessment of facilities, equipment, and staff.Conducting international pre-study visits, site initiation visits, and close-out visits.Monitoring clinical studies (remote and on-site) to ensure compliance with protocol, GCP, ICH-GCP, and MDR regulations.Supporting and advising investigators and site staff.Providing training to site teams and sponsors.Coordinating investigator meetings.Following up on patient recruitment and retention.Ensuring timely and accurate reporting of Adverse Events (AE) and Serious Adverse Events (SAE).Managing the Trial Master File (TMF) and Investigator Site Files (ISF).Developing and maintaining study-specific documentation, tools, and templates.Monitoring study budgets.Working according to SOPs and contributing to continuous improvement.
Who Are We Looking For?Previous experience as a CRA is essential, including hands-on monitoring experience.Strong knowledge of MDR is required and is a significant asset.Master's or PhD degree in Life Sciences.Familiarity with GCP and ISO standards (ISO14155, ISO9001).Excellent command of German or French is a must as well as strong communication skills in English and Dutch.Willingness to travel regularly within Europe (international site visits are a key part of the role).Proactive, flexible, and results-driven, with strong attention to detail and accuracy.Strong organizational and time-management skills, capable of handling multiple priorities across different studies.Good computer skills (MS Office, EDC systems).
What We OfferA competitive salary package with benefits: company car, eco vouchers, mobile phone with subscription, comprehensive insurance package (hospitalization, income protection, pension plan), and a flat-rate expense allowance.A close-knit team of professionals with short communication lines to management.Opportunities to work on cutting-edge clinical research projects that directly contribute to safer healthcare and patient well-being.Internal coaching and external training to support continuous development.A supportive environment that values autonomy and well-being.
Ready to grow your career as a CRA in an international environment?We're happy to get to know you!