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 research studies, ensuring compliance with GCP, FDA, OHRP, and institutional policies.
- Review study records, including informed consent documents, case report forms (CRFs), source documentation, and regulatory files.
- Evaluate data integrity, protocol adherence, and the reporting of adverse events (AEs) and serious adverse events (SAEs).
- Assess the adequacy of informed consent procedures and documentation.
- Identify deviations, compliance risks, and areas for improvement, providing recommendations for corrective and preventive actions (CAPAs).
- Verify adherence to IRB-approved protocols and regulatory submissions.
Regulatory Support & Risk Mitigation:
- Assist research teams in preparing for external audits and regulatory inspections (e.g., FDA, NIH, industry sponsors).
- Provide guidance on research compliance, documentation best practices, and IRB requirements.
- Collaborate with investigators and study coordinators to resolve compliance issues and implement corrective actions.
- Monitor changes in regulatory requirements and communicate updates to research teams.
- Develop risk assessment tools and assist in the assignment of audit priorities; support the review and enhancement of standard operating procedures (SOPs).
Reporting & Documentation:
- Prepare comprehensive reports that detail monitoring and audit findings, observations, and recommendations.
- Maintain audit records and track compliance metrics for reporting to institutional leadership.
- Develop and implement audit tools and checklists to standardize quality assurance processes.
Education & Training:
- Assist in the development and delivery of training programs for research staff on regulatory compliance, GCP, and best practices.
- Provide one-on-one or group education to study teams regarding audit findings and corrective action strategies.
Marginal or Periodic Functions:
- Adheres to internal controls and reporting structure.'
- Performs related duties as required.
Knowledge/Skills/Abilities:
- Ability to approach all work activities and interactions with a high level of integrity.
- Thorough knowledge of human research protection regulations, including 45 CFR 46; 21 CFR 50, 56, 312, and 812; and GCP, and ICH guidelines.
- Prior experience in human research protection, clinical research, and/or institutional review board operations.
- Sufficient professional experience, education, and judgment to comprehend, interpret, and analyze publications and reports related to federal and state policies, procedures, and regulations.
- Excellent analytical, writing, and verbal communication skills.
- Ability to collaborate effectively with diverse stakeholders, including faculty members, committee members, department chairs, committee staff, and federal and state regulatory officials. Strong ability to multitask, self-direct, and re-prioritize tasks as needed.
- Demonstrated ability to work both independently and with teams.
- Exceptional interpersonal skills, with the ability to exercise diplomacy and flexibility when interacting with clinical research staff and those involved in UTMB's Human Research Protection Program.
- Familiarity with Clinical Trial Management Systems (CTMS), particularly OnCore.
- Understanding of research billing processes and regulations.
- Outstanding presentation, communication (oral and written), teamwork, organizational, interpersonal, critical thinking, and problem-solving skills.
- Excellent time management and prioritizing skills, ensuring the successful completion of study timelines and deliverables.
Salary Range:
Actual salary commensurate with experience.
Equal Employment Opportunity
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
Compensation