Clinical Monitoring Standards Lead
About The Position
We are seeking a Clinical Monitoring Standards Lead to build and elevate a world-class team of IVD CRAs. This role involves owning monitoring quality and audit-readiness across RDI’s diagnostic studies. You will develop systems to demonstrate study quality and status to leadership and clients, and help modernize clinical trial monitoring by embracing risk-based monitoring, real-time oversight, remote-first execution, and AI-assisted workflows. This position requires deep knowledge of regulations and monitoring standards, not just superficial familiarity. The ideal candidate is a master of the craft, capable of performing, teaching, and inspecting the work, and holding a team to a high standard.
Requirements
- Real knowledge of regulations and monitoring standards.
- Proven ability to do the work, teach the work, inspect the work, and hold a team to the standard.
- Experience building or operating a system that keeps multiple studies inspection-ready at once.
- Willingness to dig into the details of clinical trial monitoring.
- For remote candidates: a proven method for learning the business, applying standards, and managing quality across a remote team.
Nice To Haves
- Experience modernizing clinical trial monitoring with risk-based monitoring, real-time oversight, remote-first execution, and AI-assisted workflows.
Responsibilities
- Own audit-readiness across RDI’s diagnostic studies.
- Help lead a team of junior CRAs and data-entry team members.
- Review individual informed consents.
- Check source data against CRF data.
- Walk through query status.
- Review study binders.
- Finalize monitoring reports alongside the team.
- Ensure the standard holds in real work, not just in documentation.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
