Country Approval Specialist
Core
Prepare, review, and coordinate country submissions for Ethical and Regulatory approvals to support clinical trial site start-up activities.
Role type
Country Approval Associate
Builds
Regulatory compliance review packages and country-specific submission documents for clinical trials
Domain
Clinical Research / Life Sciences
Required skills
Regulatory guideline knowledge, submission coordination, document preparation, database management, negotiation, medical terminology
Preferred skills
Experience with PPD/Client SOPs, knowledge of regional/national EC regulations
Technologies
Tracking databases, office software
Responsibilities
Coordinate with internal departments and start-up CRAs for site activation alignment, maintain trial status in tracking databases, assist in developing Patient Information Sheets and Informed Consent forms, negotiate grant budgets with sites, ensure local study files are prepared per SOPs.
Seniority
Junior, 0-2 years experience
