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 execution and documentation for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial coordination, regulatory document review, study metrics analysis, vendor management, document transmission, meeting organization, translation support, system administration (eTMF, GoBalto), ICH GCP knowledge
Preferred skills
Bachelor's degree, 4+ years of experience, knowledge of Country Regulations and SOPs
Technologies
eTMF, GoBalto, MS Office, clinical trial database systems
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 and regulatory bodies, track local regulatory documents, analyze study metrics, assist with ISF and pharmacy binder distribution
Seniority
Senior, hands-on IC