Job Summary
A company is looking for a FSP CRA (Level I/II).
Key Responsibilities
- Monitor investigator sites using a risk-based approach, ensuring compliance and data accuracy
- Document observations and communicate deficiencies to clinical management promptly
- Initiate clinical trial sites and conduct trial close-out activities as per regulatory requirements
Required Qualifications and Education
- Strong background in HSA and IRB submissions, with knowledge of ECOS
- Understanding of ICH-GCP and applicable regulations
- Experience in trial status tracking and progress reporting
- Ability to facilitate communication between investigative sites and project teams
- Proficiency in completing administrative tasks, such as expense reports and timesheets
Comments