FSP Clinical Trial Coordinator - Oncology
Core
Coordinate and facilitate project activities for clinical trials, serving as a cross-functional liaison and study lead.
Role type
Senior Clinical Trial Coordinator (Oncology)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Oncology
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 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 global support systems, support RBM activities, process documents for client (e)TMF, schedule meetings and take minutes, track local regulatory documents, transmit documents to client and IRB/IEC, analyze and reconcile study metrics, maintain vendor trackers, assist with ISF and Pharmacy binder distribution
Seniority
Senior, hands-on IC