Clinical Research Associate II | Part-Time CRA II - Klinischer Monitor (0.8 FTE) (m/w/d)
Thermo Fisher Scient. Messt. GmbH
Job Summary
This part-time (0.8 FTE) position involves coordinating and performing all aspects of clinical monitoring and site management for life-changing therapies. As a CRA II, you will conduct both remote and on-site visits to ensure protocol and regulatory compliance, managing documentation and acting as a site process specialist. Your day-to-day will include risk-based monitoring, root cause analysis, and ensuring data accuracy through SDR/SDV reviews. You will build collaborative relationships with investigative sites and ensure audit readiness in accordance with ICH-GCP guidelines. This role is highly attractive for its flexibility, offering home-based, office-based (Munich or Karlsruhe), or hybrid work arrangements within a global leader in clinical research. It provides a unique opportunity to contribute to high-quality clinical studies across 100+ countries while maintaining a balanced 32-hour work week.
Required Skills
Education
Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification.
Experience
- 2+ years of experience as a clinical research monitor
- Professional experience in clinical monitoring and site management processes
- Demonstrated experience in risk-based monitoring and critical thinking for site compliance
- Experience in managing investigational product inventory and records review
Languages
Additional
- Valid driver's license required; Full right to work in Germany; Travel requirement of 50-75%; Capability to conduct interviews in German; Available for 0.8 FTE (part-time) schedule.