FSP Clinical Trial Coordinator
Core
Coordinate and facilitate clinical trial project activities, serving as a cross-functional liaison and study lead for assigned trials.
Role type
Senior Clinical Trial Coordinator
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 department, internal, country, and investigator file reviews; Ensure tasks are completed on time, within budget, and to high quality; Support maintenance of study documentation and global support systems; Provide system support for GoBalto and eTMF; Support RBM activities; Process documents for client (e)TMF; Schedule and organize client/internal meetings; Review and track local regulatory documents; Transmit documents to client and IRB/IEC; Analyze and reconcile study metrics; Maintain vendor trackers; Assist with coordination of Investigator Site File and Pharmacy binders; Assist with study-specific translation materials and QC.
Seniority
Senior, hands-on IC