FSP Country Approval Associate
Core
Prepare, review, and coordinate country submissions for clinical trial site start-up activities in alignment with global strategy.
Role type
Country Approval Associate (Clinical Trial Operations)
Builds
Regulatory compliance review packages and country-specific study documentation for clinical trial sites
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Regulatory guidelines knowledge, submission coordination, document preparation, site activation alignment, database management, negotiation, medical terminology
Preferred skills
None stated
Technologies
Company or client tracking databases
Responsibilities
Prepare and review local EC and MoH submissions; Coordinate with internal departments for site start-up alignment; Maintain trial status information in tracking databases; Assist in developing Patient Information Sheets and Informed Consent forms; Negotiate grant budgets with sites; Maintain country study files per SOPs
Seniority
Junior (0-2 years experience)
