Description
Coordinate and document clinical quality assurance activities, including audits, inspection readiness, SOP management, TMF oversight, and vendor quality. Provide GCP guidance and quality reviews to ensure compliant studies, reliable data, and subject safety.
- • Review patient-facing materials and IP handling instructions for regulatory and protocol compliance.
- • Verify 21 CFR Part 11/Annex 11 compliance of trial electronic systems.
- • Participate in RBQM activities, including risk assessments, central monitoring, and escalation paths.
- • Coordinate document control, versioning, and periodic review of controlled documents.
- • Recommend and implement process improvements based on trends and new guidance.
- • Support management of protocol deviations, data queries, and issue logs to timely closure.
- • Collaborate with pharmacovigilance to verify SAE reporting and safety plan compliance.
- • Audit IP storage, accountability, and labeling for compliance with GCP and study plans.
- • Monitor emerging regulations and inspection trends and disseminate relevant updates.
- • Contribute quality content to project quality plans and study start-up activities.
- • Provide QA input to data management on edit checks, data flow, and database lock readiness.
- • Manage TMF archival and retention per regulations and company policy.
- • Oversee CRO monitoring performance via quality reviews and targeted audits.
- • Facilitate triage and disposition of clinical deviations, incidents, and complaints.
- • Participate in quality councils and support inputs for management review.
- • Document all QA activities to ensure traceability and compliance.
- • Communicate with clinical sites, CROs, and inspectors on GCP expectations, inspection logistics, and follow-up.
- • Plan, schedule, and conduct internal, vendor, and investigator site audits using a risk-based approach.
- • Prepare audit agendas, perform interviews and record reviews, and issue clear audit reports.
- • Track findings, perform root cause analysis, and coordinate CAPAs and effectiveness checks.
- • Lead inspection readiness activities, including mock inspections and storyboard preparation.
- • Coordinate preparation and submission of inspection responses and manage commitment timelines.
- • Interpret GCP/ICH and regional regulations and translate updates into SOPs and work instructions.
- • Review protocols, ICFs, IBs, eCRFs, monitoring plans, and CSRs for accuracy and compliance.
- • Advise study teams on deviation management, data integrity, and informed consent processes.
- • Maintain eQMS records for deviations, CAPA, change control, training, and audit logs.
- • Oversee TMF quality, perform periodic QC, and drive completeness, timeliness, and accuracy.
- • Develop and deliver GCP and SOP training and quality briefings to teams and vendors.
- • Establish and monitor clinical quality metrics, KQIs, and QTLs; escalate trends and risks.
- • Assess and qualify clinical vendors and laboratories; maintain supplier quality documentation.
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
