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College of American PathologistsPosted 2 months ago

Clinical Monitoring Standards Lead

RemoteLos Angeles, California, United States

Full TimeSenior LevelSmall

Job Summary

Lead audit-readiness and monitoring quality across RDI's diagnostic studies, develop systems that demonstrate study quality and status to leadership and clients, and drive modernization of clinical trial monitoring toward risk-based, real-time, remote-first workflows with AI-assisted tools. Own oversight of monitoring quality, assist in building and guiding a team of junior CRAs and data-entry staff, and conduct detailed tasks such as reviewing informed consent, source data, queries, binders, and monitoring reports to ensure inspections-ready status.

Required Qualifications

  • Experience in clinical monitoring/CRA roles
  • Strong regulatory knowledge (GxP, ICH) and monitoring standards
  • Experience enabling audit-readiness across studies
  • Ability to own and improve monitoring systems for multiple studies
  • Experience leading or mentoring junior team members (CRAs, data-entry)
  • Familiarity with risk-based monitoring, real-time oversight, and remote-first workflows
  • Ability to review informed consent, source data, CRF data, queries, and monitoring reports
  • Strong attention to detail and accountability for standard-holding

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