Clinical Trial Coordinator I
Core
Provide administrative and technical support to the Project Team for clinical trials, acting as a cross-functional liaison and ensuring tasks are completed on time, within budget, and to a high quality standard.
Role type
Clinical Trial Coordinator
Builds
Clinical trial operations and documentation for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Study documentation management, Regulatory document review, Study metrics analysis, Vendor tracker maintenance, Meeting coordination, Translation support, Clinical trial database systems proficiency, MS Office proficiency
Preferred skills
Medical or science related degree, PPD clinical training completion
Technologies
GoBalto, eTMF, Clinical trial database systems
Responsibilities
Coordinate and oversee assigned trial activities per task matrix; Perform file reviews (department, internal, country, investigator) and document findings; Ensure tasks are performed on time, within budget, and to high quality standards; Maintain study-specific documentation and local/global support systems; Support RBM activities; Process documents for client (e)TMF and perform mass mailings; Review and track local regulatory documents; Transmit documents to client and centralized IRB/IEC; Analyze and reconcile study metrics and findings reports; Assist with coordination of Investigator Site File (ISF) and Pharmacy binder materials; Assist with study-specific translation materials and QC.
Seniority
Individual Contributor
