資深臨床試驗專員Senior Clinical Research Associate

BE study/New drugs/Medical devices
1. Support study management activities for Project Manager.
2. Coordinate study logistics to meet project milestones.
3. Perform Site monitoring activities in compliance with GCP from pre-study to close-out.
4. Prepare project-specific support materials and templates in accordance with protocol and other specifications.
5. Communication between sponsor and site.
6. Contract negotiation of study budgets.
7. Manage activities and interactions with contractors, and/or vendors.
8. Audits/regulatory inspection preparation and participation upon request.
9. Provide mentorship and training to junior CRAs and other clinical staff as needed.