Assistant CRA - FSP (m/f/d)
Core
Remote site management and monitoring for clinical trials, ensuring compliance with regulations and supporting site performance through data review and communication.
Role type
Assistant Clinical Research Associate (Remote Monitoring)
Builds
Clinical trial data integrity and site compliance for global therapeutic areas
Domain
Clinical Research / Life Sciences
Required skills
ICH GCP knowledge, risk-based monitoring, root cause analysis, medical terminology, EDC systems, regulatory document management, site performance evaluation, data trend analysis, audit readiness
Preferred skills
Prior clinical research experience (0-1 year), German language fluency, mentorship of site personnel, advanced problem-solving
Technologies
EDC systems, CTMS, eTMF, MS Office
Responsibilities
Review study data and logs remotely, conduct site management calls, track enrollment and violations, investigate site performance issues, assist with regulatory reviews, provide trial status reports, support audit readiness
Seniority
Entry-level, aspiring CRA