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.

Key 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

Qualifications

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

Preferred

ASQ Auditor, Clinical Trial Manager, or related certification

Experience working with CROs, sponsors, and regulatory agencies

Experience conducting external or vendor audits

Must be local to Orange County & Pomona areas/This is not a remote position

Benefits

Medical, Dental, and Vision Insurance

401(k) with company match

Paid Time Off (PTO)