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
- 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