Clinical Research Associate

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).