Clinical Trial Coordinator
Core
Senior Clinical Trial Coordinator providing administrative and technical support to project teams, coordinating trial activities, and serving as a cross-functional liaison.
Role type
Senior Clinical Trial Coordinator
Builds
Clinical trial operations and documentation for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Trial activity coordination, (e)TMF management, regulatory document review, study metrics analysis, vendor tracker maintenance, ISF/Pharmacy binder coordination, translation support, meeting organization, system support (GoBalto)
Preferred skills
Bachelor's degree, 4+ years experience, knowledge of ICH GCP and country regulations, MS Office proficiency, clinical training completion
Technologies
GoBalto, eTMF, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate and oversee 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 standards; Maintain study-specific documentation and global support systems; Support RBM activities; Process documents for client (e)TMF; Transmit documents to client and centralized IRB/IEC; Analyze and reconcile study metrics; Assist with coordination of Investigator Site File (ISF) and Pharmacy binder materials
Seniority
Senior, hands-on IC