Specialist, Quality Assurance

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About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

To learn more about Care Access, visit www.CareAccess.com.

How This Role Makes a Difference

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the success of the Quality Assurance Department and organizational compliance activities. The Quality Assurance Specialist will be responsible for closely monitoring the quality and compliance of clinical work at both traditional trial sites and decentralized trials.QA specialist will directly support of quality initiatives, audit functions, CAPA systems and promote inspections readiness. Working in support of the Associate Director of Quality Assurance, the Quality Assurance Specialist will ensure that Care Access maintains a high level of quality while executing clinical trials according to Care Access SOPs, GCP, and FDA/ICH Guidelines.

How You'll Make An Impact

• Site-Level Quality & Data Integrity: Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews, site quality support, and assurance compliance with Standard Operating Procedures.

• GCP Regulatory Document Review: Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed and maintained per GCP standards.

• Audit Execution & Tracking: Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management.

• Issue Resolution & CAPA Management: Partner directly with research staff and Principal Investigators (PIs) to resolve identified compliance issues, developing, tracking, and monitoring Corrective and Preventative Action (CAPA) plans.

• External Audit & Inspection Support: Coordinate and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies.

• Quality Systems Administration: Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance…