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