FSP Clinical Trial Coordinator I
Core
Administrative and technical support for clinical trial site activation, feasibility, and regulatory compliance across global projects.
Role type
Clinical Trial Coordinator I (Central/Local)
Builds
Site activation critical paths, Investigator Site Files (ISF), regulatory compliance packages, and feasibility plans for pharmaceutical/biotech clients.
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
eTMF system management, regulatory guideline knowledge, site feasibility analysis, document review, project coordination, data reconciliation, meeting minutes preparation
Preferred skills
Veeva Vault experience, local market knowledge, cross-functional stakeholder communication
Technologies
eTMF (Activate & Veeva Vault), MS Office, CTMS
Responsibilities
Coordinate assigned trial activities per task matrix; perform file reviews (department, internal, country, investigator); ensure tasks are completed on time and within budget; provide system support for eTMF and database maintenance; process documents for client (e)TMF; analyze and reconcile study metrics; assist with ISF and pharmacy binder compilation; conduct on-site feasibility visits (Asia Pac); support regulatory submissions and local regulatory document tracking; liaise with Global Investigator Services; train new personnel.
Seniority
Individual Contributor, ~3 years experience preferred
