Clinical Research Quality Assurance and Audit Prep Lead

About Denali Health

Denali Health is an Independent Research Organization conducting Phase I–IV clinical trials across psychiatry, neurology, wound care, vaccines, and pediatrics. We operate dedicated research sites in Atlanta and Plant City and partner with leading sponsors and CROs to deliver clean, audit-ready data on every study.

The Role

We are hiring a Central Quality Assurance & Audit Prep Lead to own inspection readiness across our entire portfolio. This is not a paper-pushing QA role. You will be the person who finds the issue before the CRA does, before the sponsor auditor does, and long before an FDA inspector ever walks through the door.

You will sit horizontally across both sites and every active protocol, continuously verifying that our source data, regulatory documentation, and sponsor system entries (EDC, IRT/IWRS, ePRO, central lab portals, imaging portals, safety reporting platforms) are complete, accurate, and reconciled at all times.

What You'll Own

• Source verification in CRIO — ALCOA-C review of every active subject's eSource on a defined cadence; flag and drive resolution of incomplete, unsigned, or inconsistent documentation.
• Regulatory binder integrity — Continuous audit of eReg: 1572s, CVs, licenses, training, financial disclosures, IRB approvals and continuing reviews, protocol signature pages, delegation logs, lab certifications.
• Sponsor system reconciliation — Cross-check CRIO source against EDC, IRT/IWRS dispensing records, ePRO, central lab data, and any other sponsor-mandated portal. Catch mismatches in vitals, dosing, AEs, ConMeds, and lab values before they become findings.
• AE/SAE traceability — Verify every AE in source appears in EDC, every SAE was reported within sponsor timelines with documentation, and all follow-ups are closed.
• Protocol deviation oversight — Maintain the single source of truth for PDs across studies; ensure proper categorization, reporting, and CAPA closure.
• IP accountability — Reconcile dispensing, returns, temperature excursions, and destruction against IRT and EDC records.
• Query aging and trend analysis — Track open queries, root-cause recurring patterns, and partner with site leadership on retraining when needed.
• Pre- and post-monitoring visit prep — Ready the site before CRA arrival; drive follow-up letter action items to closure within sponsor-required windows.
• Internal mock audits — Run BIMO-style inspections per study, produce findings reports, assign and verify CAPAs.
• Quality dashboard for leadership — Monthly reporting on SDV pass rate, query aging, regulatory expiry calendar, deviation trends, and findings by site/PI/CRC.

What We're Looking For

• 3+ years in clinical research with hands-on experience in QA, monitoring, or senior CRC/regulatory work
• Deep working knowledge of ICH-GCP, 21 CFR Parts 11/50/54/56/312, and ALCOA-C principles
• Proficiency in CRIO (eSource and eReg) is strongly preferred
• Comfort working across multiple sponsor EDC platforms (Medidata Rave, Veeva, Oracle, etc.) and IRT/IWRS systems
• A pattern-recognition mindset — you spot the anomaly in a 200-row export and you know which finding kills a site at audit
• Strong written communication; you can document a finding and a CAPA cleanly
• Self-directed and organized; this role drives its own cadence across multiple studies

Why This Role

You will report directly to the VP of Clinical Operations and have visibility into every study we run. The work you do directly determines whether sponsors return for the next study. We measure this role on outcomes — clean audits, fast query resolution, zero critical findings — not on hours logged.

How to Apply

We want to hear and see you, not just read your resume.

Send a 2–4 minute video introduction to talent@denali-health.com along with your resume.

In the video, please cover:

• Your background in clinical research and what drew you to QA / audit readiness specifically
• A concrete example of a finding you caught (or wish someone had caught) — what was it, how did you find it, and what was the outcome?
• Which EDC, IRT, and eSource/eReg systems you've worked in
• What your first 30 days in this role would look like

Subject line: Central QA & Audit Prep Lead — [Your Name]

We review every video personally. Applications without a video will not be prioritized.

Denali Health is an equal opportunity employer. We are committed to building a team that reflects the diversity of the patients and communities we serve.

Work Location: Remote