Clinical Study Administrator
Core
Coordinates and administers clinical studies from start-up to close-out, ensuring document compliance and operational readiness for regulatory authorities.
Role type
Clinical Study Administrator
Builds
Interventional clinical studies
Domain
Life Sciences / Clinical Research
Required skills
Document management, Regulatory submission support, eTMF/ISF maintenance, Contract preparation support, Payment processing, Meeting coordination, Data entry in clinical systems, Translation support, Audit/inspection preparation, Vendor liaison
Preferred skills
Knowledge of ICH-GCP guidelines, Advanced computer skills, Training others on procedures, Multi-tasking in high-volume environments
Technologies
Veeva Clinical Vault, SAP S/4HANA, Coupa, ANGEL, CTMS (VCV, SharePoint)
Responsibilities
Collects and tracks documents for EC/IRB and regulatory submissions; Maintains local eTMF and ISF for inspection readiness; Prepares and supports site-level contract preparation; Processes HCO/HCP payments; Coordinates study materials and equipment; Facilitates study team and investigator meetings; Supports audits and regulatory inspections.
Seniority
Mid-level, hands-on IC
