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Senior CRA

  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 9 days ago

Senior Clinical Research Associate (Senior CRA) full home based that requires 5-7 sites per month in Germany.

Skills and Experience

Feasibility conduct; Collecting docs for regulatory submission; Supporting site contract negotiations; Supporting site issues resolution; Site Management; On-site monitoring experience in Germany 1+ years.

  • Performing site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable requirements
  • Ensuring overall integrity of study and adherence to guidelines, protocol, and regulations
  • Taking an active role in the project team by providing feedback and suggestions for successful completion of the project
  • ​Coaching and mentoring less experienced CRAs to assist in their development and training

Requirements

  • University degree in life sciences/pharmacy/biotechnology
  • At least 2-3 years of independent monitoring experience (including pre-study, initiation, routine monitoring, and close-out visits) according to protocol monitoring guidelines, SOPs, GCP/ICH Guidelines
  • Deep knowledge of monitoring procedures and entire clinical trial process
  • Computer competency
  • Fluent command of English
  • Ability to complete tasks in an accurate and timely manner

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