Clinical Research Associate
Barrington James · München, Bayern ·
Senior CRA Key Responsibilities Act as the primary contact for assigned clinical study sites in Germany. Conduct PSV, SIV, IMV, and COV visits, ensuring quality and compliance with the Monitoring Plan, SOPs, ICH-GCP, and applicable regulations.
Support study start-up, including feasibility, site selection, and site initiation activities. Manage essential and regulatory documentation and ensure timely completion. Support investigator, client, and project team meetings and training.
Develop site-level patient enrollment strategies. Ensure appropriate management and accountability of Investigational Products (IP) and trial materials. Conduct on-site and remote monitoring and provide regular site updates to the Clinical Project Manager.
Support other project-specific activities as required. Requirements Min 5 years of clinical research experience, preferably as a CRA or in a related role in South Germany. Monitoring background in COPD or Transplants. Strong knowledge of KGCP, ICH-GCP, and regulatory requirements. Able to communicate in German and English (B2–C1 level).