Clinical trial coordinator
Core
Coordinate and facilitate clinical trial activities, serving as a cross-functional liaison and study lead for assigned trials.
Role type
Senior Clinical Trial Coordinator
Builds
Clinical trial operations and documentation
Domain
Pharmaceutical/Biotech clinical 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
Preferred skills
Bachelor's degree, 4+ years of relevant experience, knowledge of ICH GCP and country regulations
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, review local regulatory documents, analyze and reconcile study metrics, assist with site file and supply distribution.
Seniority
Senior, hands-on IC