Research Compliance QA/QI Manager

About the role

The Office of Research Compliance (ORC) at the University of North Texas Health Science Center is located within the Division of Research & Innovation (DRI). The ORC works with offices responsible for specific components of research compliance and university research oversight committees such as the Institutional Review Board, Institutional Biosafety, Institutional Animal Care and Use, Research Conflict of Interest committees and the Export Control/Research Security/International Compliance Office to ensure the responsible conduct of research and compliance with university policies and federal regulations related to research activity. The office oversees development and implementation of policies, procedures, and educational activities which satisfy university policies, state, and federal regulations governing the conduct of research. The ORC is responsible for monitoring regulatory updates and making recommendations to the university to ensure compliance.

Responsibilities

• Complete routine post-approval monitoring visits/audits for research studies;
• Implement Quality Improvement Initiatives;
• Maintain and monitor implemented corrective action plans for human subjects research, providing reports on effectiveness and suggesting necessary changes;
• Complete monitoring and reporting activities for various quality improvement projects within the department (for IACUC, IRB, RCOI, ORSIC), identifying trends and areas for improvement;
• Assist with accreditation efforts for both the animal care and use program (AAALAC) and the human research program (AAHRPP);
• Work closely with the ORC AVP on training, outreach, and communications to facilitate regulatory compliance, foster a culture of research integrity, promote responsible conduct of research initiatives, and provide regulatory expertise & guidance to support the HSC and NTR IRB research communities;
• Stay updated on changes in regulations and standards related to research compliance and integrate them into organizational practices;
• Prepare detailed reports on audit findings, quality improvement initiatives, and compliance status for leadership and stakeholders;
• Lead initiatives to enhance the organization's research compliance framework and promote a culture of ethical research practices.

Requirements

• Bachelor's degree and five (5) years of relevant professional experience; or any equivalent combination of education and experience.
• Working knowledge of applicable federal regulations governing IRB, IACUC, RCOI, research integrity, and research security.
• Experience conducting audits, compliance reviews, or investigations.
• Demonstrated experience implementing and maintaining policies, as well as managing programs and training.
• Exceptionally strong analytical, organizational, communication skills (written, verbal, presentation skills) as well as strong interpersonal skills.
• Demonstrated ability to work independently with minimal oversight or direction.
• High level of maturity, diplomacy, integrity and strict confidentiality.
• Willingness and desire to partake in professional development opportunities.
• Ability to work across disciplines.

Qualifications

• Minimum Qualifications: Bachelor's degree and five (5) years of relevant professional experience; or any equivalent combination of education and experience.
• Preferred Qualifications: 4 years human subject research experience or 4 years in research compliance-related role. Prior experience with critical thinking, project management, document management and client interactions; 5-7 years across all categories in hospital research setting, university, or clinical research operation. Certifications such as: Certified IRB Professional (CIP), Certified Professional IACUC Administrator (CPIA), Certified Research Administrator (CRA), Certified in Healthcare Research Compliance (CHRC). Familiarity with accreditation standards (e.g., AAHRPP, AAALAC). Experience with international research compliance, research misconduct processes, or export control oversight. Proficiency in using electronic research administration systems (e.g., IRBNet, GRAMS, CoreStream).

Skills and Abilities

• Working knowledge of applicable federal regulations governing IRB, IACUC, RCOI, research integrity, and research security.
• Experience conducting audits, compliance reviews, or investigations.
• Demonstrated experience implementing and maintaining policies, as well as managing programs and training.
• Exceptionally strong analytical, organizational, communication skills (written, verbal, presentation skills) as well as strong interpersonal skills.
• Demonstrated ability to work independently with minimal oversight or direction.
• High level of maturity, diplomacy, integrity and strict confidentiality.
• Willingness and desire to partake in professional development opportunities.
• Ability to work across disciplines.