Clinical Trial Coordinator
Core
Coordinate and facilitate clinical trial activities, acting as a cross-functional liaison and study lead to support project teams and ensure trials are completed on time, within budget, and to high quality standards.
Role type
Senior Clinical Trial Coordinator (Central or Local)
Builds
Clinical trial execution and closeout for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial database systems, (e)TMF management, regulatory document review, study metrics analysis, vendor tracker maintenance, ISF/Pharmacy binder coordination, translation QC
Preferred skills
4+ years of relevant experience, knowledge of ICH GCP and country regulations, MS Office proficiency
Technologies
GoBalto, eTMF, clinical trial database systems
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 (e)TMF; transmit documents to client and IRB/IEC; analyze and reconcile study metrics; assist with site supply distribution.
Seniority
Senior, hands-on IC
