Clinical Research Quality Assurance Specialist

Denali Health

Plant City, FLFull-timePosted May 6, 2026

Behavioral Health Market Context

Latest national behavioral health workforce report (2026-W22)Florida behavioral health workforce newsBrowse all behavioral health workforce news
Apply Nowvia LinkedIn

Qualifications

  • •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
  • •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
  • •Which EDC, IRT, and eSource/eReg systems you've worked in
  • •4 more items(s)

Responsibilities

  • •We are hiring a Central Quality Assurance & Audit Prep Lead to own inspection readiness across our entire portfolio
  • •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
  • •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
  • •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
  • •Your background in clinical research and what drew you to QA / audit readiness specifically
  • •What your first 30 days in this role would look like
  • •15 more items(s)
Apply for this Position

More Jobs