UNT Health Fort Worth · 2 months ago
Research Compliance QA/QI Manager
Fort Worth, TX
Full-time
Onsite
Senior Level
5+ years expUNT Health Fort Worth is part of the University of North Texas System, dedicated to excellence and innovation in education. They are seeking a Research Compliance QA/QI Manager to oversee compliance audits and quality improvement initiatives, ensuring adherence to federal, state, and institutional regulations governing research activities.
EducationHealth CareNon ProfitUniversities
Responsibilities
Complete routine post-approval monitoring visits/audits for research studies
Implement Quality Improvement Initiatives
Monitor implemented corrective action plans for human subjects research, provide reports on effectiveness and/or suggest 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
Qualification
Required
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
Preferred
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)
Company
UNT Health Fort Worth
UNT Health Fort Worth opened its doors in 1970 as the Texas College of Osteopathic Medicine.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$152MKey Investors
Tarrant CountyNational Institutes of HealthBlue Cross and Blue Shield of Texas
2022-12-13Grant· $2M
2022-10-03Grant· $150M
2022-07-07Grant
Leadership Team
Kimberly Russell
Vice President
Kemp Louis
EVP Administration and Chief Business Officer
Recent News
2025-08-18
2025-05-05
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