FSP Clinical Trial Coordinator I
Core
Administrative and technical support for clinical trial site activation, feasibility, and audit readiness across global pharmaceutical and biotech projects.
Role type
Clinical Trial Coordinator (Site Activation & Feasibility)
Builds
Site activation critical paths, feasibility site lists, regulatory compliance packages, and study documentation systems.
Domain
Clinical Research / Pharmaceutical Services
Deliverable
client delivery
Required skills
eTMF system management, site feasibility analysis, regulatory document review, study metrics reconciliation, vendor tracker maintenance, meeting minute documentation, local regulatory knowledge, site selection support, training delivery, cross-functional collaboration.
Preferred skills
Veeva Vault experience, 3+ years clinical research experience, Bachelor's degree, on-site feasibility visit execution.
Technologies
eTMF (Activate & Veeva Vault), CTMS, MS Office (Word, Excel, PowerPoint), clinical trial database systems.
Responsibilities
Coordinate and oversee assigned trial activities per task matrix; perform file reviews (department, internal, country, investigator); ensure tasks are completed on time and within budget; manage system databases and document processing; analyze and reconcile study metrics; assist with ISF and pharmacy binder compilation; support regulatory submissions and site start-up alignment; conduct on-site feasibility visits (Asia Pac); train new personnel; liaise with Global Investigator Services.
Seniority
Mid-level, hands-on IC