Clinical Trial Coordinator
Core
Coordinate and facilitate clinical trial activities, serving as a cross-functional liaison and study lead to ensure projects are completed on time, within budget, and to high quality standards.
Role type
Senior Clinical Trial Coordinator (Central or Local)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports for pharmaceutical and biotech clients
Domain
Clinical Research / Pharmaceutical Trials
Required skills
Clinical trial database systems, (e)TMF management, regulatory document review, study metrics analysis, vendor tracker maintenance, ISF/Pharmacy binder coordination, translation QC, MS Office proficiency
Preferred skills
4+ years of relevant experience, knowledge of ICH GCP and country regulations, ability to act as a study lead, training new staff
Technologies
GoBalto, eTMF, clinical trial database systems, MS Office
Responsibilities
Coordinate assigned trial activities per task matrix; support file reviews and document findings; ensure tasks are performed on time and within budget; maintain study documentation and system access; process documents for client (e)TMF; review local regulatory documents; transmit documents to client and IRB/IEC; analyze and reconcile study metrics; maintain vendor trackers; assist with ISF and study supply distribution.
Seniority
Senior, hands-on IC
