Clinical Research Auditor & Quality Assurance Analyst - Office of Institutional Compliance
UTMB Health · Galveston, Texas, US
Clinical Research Auditor & Quality Assurance Analyst - Office of Institutional Compliance - ( 2602398 ) Description Minimum Qualifications: Bachelor’s degre...
Job description
Clinical Research Auditor & Quality Assurance Analyst - Office of Institutional Compliance - ( 2602398 ) Description Minimum Qualifications: Bachelor’s degree in healthcare administration, nursing, clinical sciences, or related discipline, and five years of clinical experience, including three years in clinical research. Preferred Licenses, Registrations, or Certifications: - Current State of Texas Professional Nursing License (RN). - Certification in clinical research (e.g., SOCRA CCRP, ACRP CCRA/CPI/CRC). Job Summary: The Clinical Research Study Auditor is responsible for conducting independent audits of clinical research studies to ensure compliance with federal regulations, Good Clinical Practice (GCP), Institutional Review Board (IRB) policies, and institutional research guidelines and policies. The auditor provides education, evaluates study documentation, regulatory compliance, data integrity, and adherence to protocol requirements. This role works closely with investigators, study teams, and regulatory bodies to uphold research integrity and the protection of human subjects. Job Duties: Compliance Review: - Conduct routine, for-cause, and focused reviews of clinical researc...