Principal CRA - Monitoring Standards & Training
$100,000–$115,000 year
Remote · United States
Job Summary
Senior clinical monitor role focused on elevating monitoring performance and teaching others. Own and evolve RDI's clinical-monitoring standard through a living rubric and a library of exemplars (query handling, deviation management, source data review, protocol-compliance judgment). Act as the senior escalation point for difficult monitoring questions while maintaining a hands-on caseload (~25–35%). Deliver real-work coaching by reviewing teammates' monitoring alongside them, using written rubrics. Collaborate remotely with offshore teams (UTC+8 overlap) and drive independence within the team. Remote-friendly US-based full-time position with base compensation $100,000–$115,000, benefits, and paid time off. Requires the ability to work asynchronously and hold overlapping hours with Manila; preferred: experience in IVD or laboratory contexts; strong teaching, mentoring, and documentation-writing skills.
Required Qualifications
- Deep monitoring craft with SDV/review and protocol-compliance judgment
- Command of clinical guidelines (GCP/ICH E6, E3) and risk-based monitoring
- Strong teaching/mentoring ability evidenced by onboarding, curricula development, co-monitoring, and oversight
- Excellent written communication; delivering practical, usable rubrics and libraries
- Remote-effective collaboration with asynchronous teams and ability to maintain 3–4 hours of daily overlap with UTC+8 (Manila)
- Ability to review real work alongside team members and elevate performance through feedback
- Comfort being a peer-expert and building independence within a self-managing team
- Experience in IVD or laboratory contexts is a plus but not required
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