Clinical Project Assistant
Core
Support the setup, administration, and archiving of electronic Trial Master Files (eTMF) for clinical registries, ensuring adherence to GCP guidelines and SOPs.
Role type
Clinical Project Assistant (eTMF Specialist)
Builds
Electronic Trial Master Files (eTMF) and registry study documentation
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
eTMF management, ICH GCP guidelines knowledge, document classification, quality control (QC), project coordination, budget tracking, SharePoint management
Preferred skills
Experience with emerging technologies and mobility applications
Technologies
eTMF systems, SharePoint, Microsoft Office
Responsibilities
Prepare and manage TMF archiving, collection, reconciliation, and filing; Upload and QC documents for existing and new sites; Coordinate project schedules and milestones; Support project budgetary tracking and site payments; Prepare correspondence and meeting minutes; Manage core file reviews and audit support; Track e-Training compliance; Coordinate onboarding of new team members.
Seniority
Mid-level, hands-on IC
