Clinical Trial Coordinator - (FSP )
Core
Provide administrative and technical support for global clinical trials, ensuring audit readiness, site activation, and regulatory compliance.
Role type
Clinical Trial Coordinator (CTC)
Builds
Clinical study documentation, site activation plans, and regulatory inspection readiness packages
Domain
Pharmaceutical/Biotech clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial operations, site activation support, regulatory inspection readiness, study documentation review, risk-based monitoring support, vendor contract administration, study close-out activities, CTMS/TMF system management
Preferred skills
Phase 2 and 3 study experience, global/international study experience, oncology therapeutic area experience, Veeva Vault proficiency, eTMF life cycle experience
Technologies
CTMS, eTMF, Veeva Vault, MS Office
Responsibilities
Review study documentation including essential document packets and informed consent forms; support risk-based monitoring activities; attend key team meetings and document minutes; support regulatory inspection readiness including SOP lists and storyboard collation; support clinical trial systems activities; assist with vendor contract administration; support study close-out activities including financial reconciliation
Seniority
Mid-level, hands-on IC