Senior Clinical Research Associate (Netherlands)

Job description

Are you seeking an exciting and fulfilling new opportunity? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives. Role Objectives: The WEP Clinical Senior Clinical Research Associate (Senior CRA) oversees all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs. They conduct on-site and remote monitoring to ensure protocol adherence, maintain essential documentation, and keep site and patient data inspection-ready. The Senior CRA builds strong relationships with sponsors and sites, serving as a key point of contact throughout the study. They may also support development of study-specific procedures (e.g., Monitoring Plans) and assist in training or coordinating other CRAs. The Ideal Candidate: Leader Detail Oriented Problem Solver Adaptable What You'll Do: Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans). Lead site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection. Planned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements. Build strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulations. Verify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-ready. Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions. Manage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrence. Track and close action items within study or company timelines; maintain clear oversight of monitoring deliverables. Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates. (Lead CRA, if assigned) Oversee monitoring on complex studies; develop study-specific monitoring documents (e.g., CMP, deviation plan, report templates); final…