What are the responsibilities and job description for the Quality Assurance Specialist position at National Institute of Clinical Research, Inc.?
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)
Salary : $55,000 - $65,000