FSP CRA II Beijing)
On-site · Beijing, Beijing, China
Job Summary
Lead Clinical Research Associate responsibilities with Fortrea: manage on-site monitoring of clinical trials per SOPs, ICH GCP, and sponsor requirements; verify training records and ensure informed consent and protocol adherence; safeguard data integrity through source document review and 100% source data verification; manage eTMF/sponsor documents, trial IP inventory, and study materials; ensure audit readiness and adherence to travel requirements; collaborate with investigators and project team; provide training and support for new staff; travel up to 60% and work in an on-site/beijing setting. Proficiency in English and local language; university degree or related licensure preferred; 2+ years monitoring experience desired.
Required Qualifications
- University or college degree, or certification in a related allied health profession (e.g., nursing licensure)
- Minimum 2 years of Clinical Monitoring experience for external candidates; internal candidates require same experience
- Fluent in English and local office language
- Understanding of ICH GCP guidelines and local regulatory requirements
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