- Collaborate with Clinical Operations to develop site initiation timelines and track project milestones.
- Prepare and manage site startup documentation, including contracts, informed consent forms, and regulatory submissions.
- Coordinate with contracts and budget teams to support timely execution of site agreements.
- Assist with preparing and submitting essential regulatory documents for site activation.
- Ensure documents are approved by ethics committees and IRBs before site activation.
- Track regulatory submissions, site contracts, and essential document collection.
- Verify site readiness, including adequate resources and completed training, before patient enrollment.
- Participate in study kick-off and initiation meetings to align expectations and timelines.
- Troubleshoot activation issues and escalate problems to the Project Manager or CRA as needed.
- Assist with setting up study supplies and equipment at sites, including investigational products and lab kits.
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