Specialist, Quality Assurance
Core
Ensure quality and compliance of clinical work at traditional and decentralized trial sites through audits, CAPA management, and regulatory document reviews.
Role type
Quality Assurance Specialist (GxP)
Builds
Clinical trial compliance and data integrity
Domain
Clinical Research / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP guidelines knowledge, GCP standards, audit execution, CAPA management, regulatory document review, SOP development, clinical terminology, federal regulations interpretation
Preferred skills
AI project quality support, digital technologies engagement, risk-based audit agenda flexibility
Technologies
clinical trials database, IVR systems, electronic data capture, MS Word, MS Excel
Responsibilities
Execute yearly corporate audit plan and track quality assurance audits, Review study-specific regulatory binders and clinical documents for GCP compliance, Partner with research staff and PIs to resolve compliance issues and manage CAPA plans, Coordinate support for on-site audits and inspections by external providers and regulatory agencies, Maintain internal quality systems, compliance trackers, and operational programs, Participate in drafting and maintaining quality assurance Standard Operating Procedures (SOPs), Provide guidance and best-practice recommendations to site personnel and clinical project teams
Seniority
Mid-level, hands-on IC