JobMesh

CRA II/SCRA I

Fortrea · Leiden, South Holland, THE NETHERLANDS

Summary of Responsibilities As a Clinical Research Associate (CRA II / Senior CRA I), you will be responsible for the end‑to‑end management and monitoring of...

Job description

Summary of Responsibilities As a Clinical Research Associate (CRA II / Senior CRA I), you will be responsible for the end‑to‑end management and monitoring of clinical trial sites, ensuring studies are conducted in compliance with Fortrea SOPs, ICH‑GCP guidelines, and applicable regulatory requirements. You will play a key role in delivering high‑quality clinical research, safeguarding patient safety, and ensuring data integrity across all study phases. Your responsibilities will include: Site Management & Monitoring Independently manage investigative sites throughout the full clinical trial lifecycle, from start‑up to close‑out Perform all monitoring visit types, including pre‑study, site initiation, routine monitoring, and close‑out visits Act as the primary point of contact for sites, building strong relationships and ensuring effective communication Patient Safety & Regulatory Compliance: Ensure the protection of study participants by verifying informed consent processes and protocol adherence Confirm site staff are appropriately trained and qualified to conduct study procedures Maintain complete, accurate, and audit‑ready regulatory documentation (including eTMF and site files)...