Position Overview
Job Responsibilities
- Establish and manage a clinical trial committee, which includes:
- Identify potential members for the committee.
- Collect member documents (NDAs, CVs, etc.) and perform initial assessments such as debarment checks and conflict‑of‑interest attestations.
- Negotiate and execute contractual agreements.
- Receive, submit, and track member invoices against the project budget and contracted services.
- Perform duties as per the Committee Charter and project plans:
- Schedule, attend, and facilitate committee meetings.
- Prepare and distribute meeting materials (agendas, minutes, etc.) and track action items.
- Distribute safety listings, expedited safety reports, protocol and other trial documents for review.
- Review clinical event/endpoint documentation to ensure completeness, appropriate PHI redaction, and identify unreported endpoints/events that req...