Principal CRA - Monitoring Standards & Training

Job Description

Job Description

About RDI

At RDI Trials, we're building a different kind of CRO.

We are an IVD-focused contract research organization. Since 2008 we've run 300+ diagnostic trials for the largest test makers in the world. Our clinical operations team is sharp, motivated, and runs its own workload well — what they need now is someone to raise the ceiling on monitoring craft.

This is not a traditional, process-heavy environment.

We are a small team that moves fast and expects people to take real ownership. There's no passing things along or waiting for direction. If something needs to get done, you step in and figure it out.

The pace is high. The expectations are high. But for the right person, it's a place where you can learn quickly and have real impact.

Those who thrive at RDI

• Take ownership and actually follow things through
• Can think for themselves and make decisions without a playbook
• Are comfortable when things are not perfectly defined
• Understand their work at a deeper level, not just surface
• Communicate clearly and directly
• Have a strong foundation in their field but are willing to step outside of it

This is a place for people who want to build, not just maintain.

The Culture

We punch above our weight class — a 30-person company running the workload of a CRO twice our size. That happens because of how we work, not how big we are.

We move with speed and discipline. We own outcomes, not tasks. Precision is non-negotiable in our work, so it's non-negotiable internally. Grit matters here — but we'd rather build the systems that scale.

The CEO sets the pace. The COO runs the operation. Leadership is accessible — you'll be in the room. Feedback is fast and unvarnished, and the worst thing you can do is hide a problem.

We just signed the largest contract in company history. The next 18 months will stretch every function, including this one.

The Role

This is a senior clinical monitor who teaches. You'll own RDI's clinical-monitoring standard, level up the team by reviewing their real work alongside them, and serve as the senior point of judgment for the hardest monitoring questions. It's a player-coach role — you keep a small live caseload (~25–35%) so your craft stays current and credible, and you spend the rest of your time making everyone around you better.

This role requires 3–4 hours of daily overlap with our offshore team UTC+8 (typically early US Pacific morning or late evening). That's the single biggest fit question — confirm it works before you apply.

The deliverable isn't visits monitored. It's a team that monitors at a higher standard and operates more independently because of you — and a written, company-owned rubric that outlasts any single study.

The Work

• Own the monitoring standard. Build and maintain a living rubric and a library of "what good looks like" — query handling, deviation management, source data review, protocol-compliance judgment — usable in real reviews, not a binder that gets shelved.
• Teach through real work. Review the team's monitoring side-by-side against the rubric. Most growth happens working through actual files together, not in lectures.
• Be the senior escalation point. Take on the judgment-heavy monitoring problems above the team's current level, and help the team escalate well — early, scoped, and prepared.
• Keep a live caseload (~25–35%). Stay hands-on so your craft stays current.
• Build for independence. Success is the team needing you less over time on competencies you've transferred, so you can move to the next gap.

What we're looking for

• Deep monitoring craft. You've set the bar others were measured against, not just met it — strong SDV/review, protocol-compliance judgment, deviation and query resolution, site management.
• First-principles command of clinical guidelines. You understand why GCP/ICH (E6, E3, risk-based monitoring) and ALCOA+ exist, not just how to cite them, and you can teach from that understanding. This matters more to us than any specific therapeutic area.
• A genuine desire to teach. Evidence that you've made other monitors better — mentoring, onboarding, training curricula, co-monitoring, oversight. This is the heart of the role.
• Writing chops. Your deliverable is a written rubric and library. Plain, precise, usable prose matters.
• Remote-effective. You collaborate well asynchronously and can hold 3–4 hours of daily overlap with Manila.
• The right temperament. You earn authority through craft, not title. You're comfortable being a peer-expert to a team that manages itself — you're not looking to manage their workload.

A plus, not a requirement: in-vitro diagnostics (IVD) or laboratory experience (clinical chemistry, hematology, immunoassay, molecular dx). We work in this space, but we'd rather hire for monitoring judgment and teaching ability and bring you up to speed on the domain.

What this role is not

• It is not a people-management or workload-coordination role — the team organizes its own work.
• It is not a desk job removed from the work — you keep monitoring.
• It is not a "write the SOPs and leave" engagement — the rubric lives through continuous review.
• It is not a stepping-stone to a Director-of-Monitoring seat — this is the senior IC craft seat.

Logistics

• Remote, US-based, full-time. Must be authorized to work in the US.
• Base compensation: $100,000–$115,000 , commensurate with experience.
• 3–4 hours of daily overlap with UTC+8 required; otherwise hours are flexible.

How we hire

We evaluate on real work, not just conversation. Expect a paid hands-on exercise — reviewing and giving feedback on a sample monitoring file — so both sides see the fit clearly before committing.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)