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. 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 ResponsibilitiesEnsure compliance with FDA, IRB, ICH-GCP, and regulatory guidelinesConduct internal quality audits and assist with sponsor/CRO auditsReview regulatory binders, source documentation, and study files for accuracy and completenessIdentify compliance gaps and support CAPA (Corrective and Preventive Actions)Assist with protocol implementation, regulatory submissions, and sponsor correspondenceConduct vendor and document audits to ensure compliance with Good Documentation Practices (GDP)Support quality management reviews and continuous improvement initiativesProvide training and guidance to research staff on QA standardsParticipate in technology implementation and review of vendor quality recordsSupport additional QA projects as neededTravel between clinical sites in Garden Grove and Pomona requiredQualificationsBachelors degree or equivalent relevant experience3 years clinical research experience and/or Quality AssuranceStrong knowledge of GCP, FDA regulations, and clinical trial complianceExperience with clinical, regulatory, or document auditingStrong organizational, analytical, and problem-solving skillsPreferredASQ Auditor, Clinical Trial Manager, or related certificationExperience working with CROs, sponsors, and regulatory agenciesExperience conducting external or vendor auditsMust be local to Orange County & Pomona areas/This is not a remote positionBenefitsMedical, Dental, and Vision Insurance401(k) with company matchPaid Time Off (PTO)

Salary : $55,000 - $65,000