Clinical Trial Coordinator - FSP
Core
Provide administrative and technical support to clinical trial project teams, ensuring audit readiness, supporting site activation, and managing study documentation.
Role type
Clinical Trial Coordinator
Builds
Clinical trial operations and site activation
Domain
Clinical research / Pharmaceutical
Required skills
Regulatory inspection readiness, site activation support, study document review, risk-based monitoring oversight, inspection readiness preparation, clinical trial systems management, vendor contract administration, study close-out support
Preferred skills
Regional/global study experience, oncology therapeutic area experience, Veeva Vault proficiency, eTMF lifecycle experience
Technologies
CTMS, TMF, Veeva Vault, Microsoft Office
Responsibilities
Support day-to-day clinical study activities including regulatory inspection readiness; Work with Clinical Operations and Study Managers to support activities defined by the clinical trial operating model; Review study documents including essential document packets, study plans, and informed consent forms; Support and provide oversight of risk-based monitoring activities; Attend key team meetings and prepare minutes; Support inspection readiness activities such as preparing SOP lists and collating inspection storyboards; Support clinical trial systems including CTMS- and TMF-related activities; Assist with vendor contract administration; Support study close-out activities including financial reconciliation
Seniority
Entry-level to Mid-level, hands-on IC
