FSP Clinical Trial Coordinator II
Core
Administrative and technical support for clinical trial site activation, feasibility assessments, and audit readiness.
Role type
Clinical Trial Coordinator II
Builds
Site activation critical paths, feasibility assessments, regulatory compliance packages, and study documentation.
Domain
Clinical Trials / Pharmaceutical Services
Deliverable
client delivery
Required skills
Site activation coordination, feasibility assessment, regulatory document review, (e)TMF management, site list development, data reconciliation, SOP compliance, stakeholder communication
Preferred skills
Local market knowledge, translation support, system administration, training new personnel
Technologies
(e)TMF, Activate, clinical trial databases, MS Office
Responsibilities
Coordinate assigned trial activities per task matrix, perform file reviews and document findings, process documents for client transfer, track local regulatory documents, analyze study metrics, maintain vendor trackers, assist with Investigator Site File compilation, support site selection and tiering, train new staff, ensure database accuracy, support regulatory submissions and start-up activities.
Seniority
Mid-level, hands-on IC