Clinical Monitoring Standards Lead

RDI • Los Angeles, CA

1d • Hybrid

About The Position

The Clinical Monitoring Standards Lead will be responsible for building and leading a world-class team of IVD CRAs. This role involves owning monitoring quality and audit-readiness across RDI’s diagnostic studies. The lead will develop systems to demonstrate study quality and status to leadership and clients, and will 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, and the ability to not only perform the work but also teach, inspect, and uphold high standards for the team. The role involves hands-on work, including reviewing informed consents, checking source data against CRF data, managing query status, reviewing binders, and finalizing monitoring reports.

Requirements

• Real knowledge of the regulations and monitoring standards.
• Ability to do the work, teach the work, inspect the work, and hold a team to the standard.
• Proven method for learning the business, applying standards, and managing quality across a remote team (for remote candidates).

Nice To Haves

• Experience building or operating a system that keeps multiple studies inspection-ready at once.

Responsibilities

• Own audit-readiness across RDI’s diagnostic studies.
• Help lead a team of junior CRAs and data-entry team members.
• Develop systems that demonstrate study quality and status to leadership and clients.
• Modernize clinical trial monitoring practices.
• Review individual informed consents.
• Check source data against CRF data.
• Walk through query status.
• Review binders.
• Finalize monitoring reports alongside the team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed