Clinical Trial Coordinator
Core
Administrative and technical support for clinical trial projects, coordinating activities, managing documentation, and serving as a cross-functional liaison.
Role type
Clinical Trial Coordinator (Central or Local)
Builds
Clinical trial study documentation, regulatory submissions, and project activity plans
Domain
Pharmaceutical/Biotech clinical research
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
Study lead experience, process improvement initiatives, training new staff
Technologies
GoBalto, eTMF, MS Office
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; 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 binder materials; Assist with study-specific translation materials and QC.
Seniority
Mid-level, hands-on IC
