Clinical Research Associate

Barrington James; München; Hybrid; EUR 52.000 - 74.000; Vollzeit

Zusammenfassung

Barrington James in Germany is seeking an experienced Clinical Research Associate to act as the primary contact for study sites in Bavaria. You will conduct site visits and ensure quality and regulatory compliance across monitoring activities.

You will support study start-up, manage essential documents, and coordinate with investigators, clients and project teams. The role involves on-site and remote monitoring and developing site updates for the Clinical Project Manager.

Qualifikationen

• Min 5 years of clinical research experience (CRA or similar) in Germany/Bavaria.
• Monitoring background in COPD or Transplants.
• Strong knowledge of KGCP, ICH-GCP and regulatory requirements.
• German and English communication at B2–C1 level.

Aufgaben

• Act as the primary contact for assigned clinical study sites in Germany.
• Conduct PSV, SIV, IMV, and COV visits with QA and compliance to ICH-GCP and SOPs.
• Support study start-up, 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.
• Ensure appropriate management and accountability of Investigational Products and trial materials.
• Conduct on-site and remote monitoring and provide site updates to the Clinical Project Manager.
• Support other project-specific activities as required.

Kenntnisse

Site monitoring

GCP knowledge

German & English

Jobbeschreibung

• 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.
• 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).