Quality Assurance Specialist

National Institute of Clinical Research is seeking an experienced Quality Assurance Specialist to oversee the accuracy, compliance, and integrity of clinical research data and documentation across our clinical research sites in Garden Grove and Pomona.

Requirements

• Ensure compliance with FDA, IRB, ICH-GCP, and regulatory guidelines
• Conduct internal quality audits and assist with sponsor/CRO audits
• Review regulatory binders, source documentation, and study files for accuracy and completeness
• Identify compliance gaps and support CAPA (Corrective and Preventive Actions)
• Assist with protocol implementation, regulatory submissions, and sponsor correspondence
• Conduct vendor and document audits to ensure compliance with Good Documentation Practices (GDP)
• Support quality management reviews and continuous improvement initiatives
• Provide training and guidance to research staff on QA standards
• Participate in technology implementation and review of vendor quality records
• Support additional QA projects as needed
• Travel between clinical sites in Garden Grove and Pomona required

Benefits

• Medical, Dental, and Vision Insurance
• 401(k) with company match
• Paid Time Off (PTO)