Clinical Trial Coordinator
Core
Administrative and technical support for clinical trial site activation, file reviews, and regulatory compliance across global projects.
Role type
Clinical Trial Coordinator (Site Activation & Documentation)
Builds
Site activation critical paths, Investigator Site Files (ISF), regulatory compliance packages, and study documentation systems.
Domain
Clinical Research / Pharmaceutical Services
Deliverable
client delivery
Required skills
Site selection and management, (e)TMF administration, regulatory document review, study metrics analysis, vendor tracking, local regulatory knowledge, SOP adherence, system database maintenance, translation coordination
Preferred skills
Bachelor's degree, 0-1 years experience, local market expertise
Technologies
Activate, eTMF, CTMS, MS Office
Responsibilities
Coordinate assigned trial activities per task matrix; perform department, internal, country, and investigator file reviews; ensure tasks are completed on time and within budget; process and review documents for client (e)TMF; analyze and reconcile study metrics; assist with ISF and pharmacy binder compilation; support regulatory submissions and local regulatory document tracking; liaise with Global Investigator Services; train new personnel on processes and systems.
Seniority
Entry-level, hands-on IC
