Quality Assurance Specialist

National Institute of Clinical Research, Inc.•Irvine, CA

35d•Onsite

About The Position

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. This role ensures compliance with FDA, IRB, and Good Clinical Practice (GCP) guidelines while protecting research participants and maintaining high-quality clinical trial operations.

Requirements

Bachelor’s degree or equivalent relevant experience
3+ years clinical research experience and/or Quality Assurance
Strong knowledge of GCP, FDA regulations, and clinical trial compliance
Experience with clinical, regulatory, or document auditing
Strong organizational, analytical, and problem-solving skills
Must be local to Orange County & Pomona areas/This is not a remote position

Nice To Haves

ASQ Auditor, Clinical Trial Manager, or related certification
Experience working with CROs, sponsors, and regulatory agencies
Experience conducting external or vendor audits

Responsibilities

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