FSP Trial Delivery Specialist - Clinical Trial Coordinator
Core
Coordinate and facilitate project activities for clinical trials, acting as a cross-functional liaison and study lead.
Role type
Senior Clinical Trial Coordinator (FSP Trial Delivery)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Pharmaceutical Trials
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
Bachelor's degree, 4+ years experience, PPD clinical training completion
Technologies
GoBalto, eTMF, MS Office
Responsibilities
Coordinate assigned trial activities per task matrix, perform file reviews and document findings, ensure tasks are completed on time and within budget, maintain study documentation and system access, support RBM activities, process documents for client (e)TMF, schedule meetings and take minutes, review local regulatory documents, transmit documents to IRB/IEC, analyze and reconcile study metrics, maintain vendor trackers, assist with ISF and pharmacy binder distribution
Seniority
Senior, hands-on IC