Principal CRA - Monitoring Standards & Training

RDI

2d•$100,000 - $115,000•Remote

About The Position

This is a senior clinical monitor role focused on teaching and elevating the monitoring standards within the organization. The individual will own the clinical monitoring standard, develop a living rubric and library of best practices, and mentor the team by reviewing their real work. The role involves serving as the senior point of judgment for complex monitoring issues and maintaining a small live caseload to stay current. Success is measured by the team's increased independence and higher monitoring standards, supported by a lasting company-owned rubric.

Requirements

Deep monitoring craft, including strong SDV/review, protocol-compliance judgment, deviation and query resolution, and site management.
First-principles command of clinical guidelines, including GCP/ICH (E6, E3, risk-based monitoring) and ALCOA+.
A genuine desire and demonstrated ability to teach and improve other monitors (e.g., mentoring, onboarding, training curricula, co-monitoring, oversight).
Strong writing skills for creating a written rubric and library.
Ability to collaborate effectively asynchronously and maintain 3-4 hours of daily overlap with UTC+8.
Comfort being a peer-expert to a self-managing team, without managing their workload.
Must be authorized to work in the US.

Nice To Haves

In-vitro diagnostics (IVD) or laboratory experience (clinical chemistry, hematology, immunoassay, molecular dx).

Responsibilities

Own the monitoring standard by building and maintaining a living rubric and a library of "what good looks like" examples for query handling, deviation management, source data review, and protocol-compliance judgment.
Teach through real work by reviewing the team's monitoring side-by-side against the rubric.
Serve as the senior escalation point for complex monitoring problems and guide the team on effective escalation.
Maintain a live caseload of approximately 25-35% to keep monitoring craft current.
Build for team independence by transferring competencies so the team requires less support over time.