Provide outstanding service to meet the needs of all university constituencies involved with regulated research to ensure compliance with federal, state, and local regulations and policies. This position will assist the Director of Regulatory Services with implementation and maintenance of a comprehensive research compliance program that includes training and outreach, policy and procedure development, monitoring, reporting, and enforcement. Primary compliance areas included are human subject research, animal research, conflict of interest, export control, research integrity, and research misconduct.
1. Proactively collaborates with senior administration and research community regarding compliance risks, controls, and new developments in research-related laws and regulations. Assists faculty, staff, students, and committees in interpreting federal regulations, national best practices, UTA policies/procedures, and UT System policies. 2. Provides day-to-day supervision of staff including hiring, orientation, delegation of responsibilities, evaluation, monitoring time, performance and salary actions, and dealing with problems. Assists staff in discharging their responsibilities and provides appropriate training, mentoring, and guidance. 3. Directs the preparation and submission of divisional administrative reporting requirements such as the Unit Effectiveness Process and Business Continuity Plan. Frequently engages with other University Departments regarding financial and administrative matters. Assists with preparation and monitoring of the budget. 4. Primary oversight for human research protection program: operations of the Institutional Review Board (IRB), review of research in accordance with regulations/internal SOPs, FDAIND/IDE evaluations, author and implement policies & procedures, reporting, reliance agreements, coordination with relevant UTA departments, non-compliance investigations, research monitoring, facilitating agency/sponsor audits, leadership and coordination of regional IRB working group, recordkeeping. 5. Primary responsibility to maintain the office's existing outreach and training programs and initiation and/or expansion of comprehensive campus-wide training and outreach for research COI, export control, research integrity, and related control measures for foreign influence. 6. Assist in oversight of animal research program & recombinant DNA research: operations of the Institutional Animal Care & Use Committee (IACUC) & the Institutional Biosafety Committee (IBC), implement policies & procedures, reporting, coordination with Animal Facility or other relevant departments, non-compliance investigations, post-approval monitoring, accreditation. 7. Assist in oversight of export control program: develop & monitor Technology Control Plans, export licenses, implement policies & procedures, reporting, coordinate with relevant UTA departments, expand campus-wide training & outreach, monitoring, non-compliance investigations, identify sensitive high-risk activities for export assessment. 8. Assist in oversight of research conflict of interest (COI) program: operations of the Research COI Committee, development & monitoring of Management Plans, review COI disclosures, implement policies & procedures, reporting, coordination with relevant UTA departments. 9. Assist with research integrity matters: ensure compliance with sponsor/agency training requirements for responsible conduct of research (RCR), facilitate misconduct inquiries and investigations, ensure cross-coordination between areas of research ethics/compliance and relevant UTA departments, federal/sponsor reporting. 10. Assumes responsibilities and oversight for the Director of Regulatory Services, when necessary or as delegated. Performs other duties as assigned.
Knowledge, Skills, and Abilities: Knowledge/familiarity with national best practices and flexibility options for review of human subject research. Excellent interpersonal and customer service skills. Strong time management skills and the ability to prioritize multiple tasks in an extremely fast-paced environment. High level of experience and comfort working independently with senior leaders, faculty, administrators, medical professionals, and officials of external agencies. Highly motivated with strong initiative to improve, update, and develop programs to meet user expectations and changing practices/regulatory requirements. Excellent written and verbal communication skills. Strong critical thinking skills and ability to exercise judgment and discretion in interpreting and applying a range of administrative and research policies and procedures. Ability to understand scientific jargon for the purposes of determining grant congruency and protocol/project review.
Bachelor's or Graduate Degree in a relevant scientific, research, health care, law, administration, or management discipline or the equivalent experience. Five (5) years of experience in an academic, health care, or biomedical research environment. Two (2) years of experience in IRB operations and interpreting and ensuring compliance with federal regulations pertaining to human subject research, including the Common Rule, FDA regulations, and Good Clinical Practice. Prior experience supervising personnel including hiring, training, mentoring, and evaluation. Prior experience developing, initiating, and maintaining a comprehensive training/outreach program in multiple formats (electronic, presentations, etc.).
Master's Degree in a related field and/or JD. CIP or CCRP (professional IRB certification), CPIA (professional IACUC certification). Prior experience interpreting and ensuring compliance with federal regulations pertaining to animal research (Animal Welfare Act/Regulations, PHS Policy, AAALAC program requirements), rDNA research (NIH Guidelines, CDCBMBL), export control (EAR, ITAR, OFAC), research COI (PHS regulations), research integrity/misconduct (NSF, NIH, PHS Policy).
Applicants must include in their online resume the following information: 1) Employment history: name of company, period employed (from month/year to month/year), job title, summary of job duties and 2) Education: school name, degree type, and major.
UTA is an Equal Opportunity/Affirmative Action institution. Minorities, women, veterans and persons with disabilities are encouraged to apply. Additionally, the University prohibits discrimination in employment on the basis of sexual orientation. A criminal background check will be conducted on finalists. The UTA is a tobacco free campus.
Open Until Filled: No
Internal Number: 11122
About University of Texas at Arlington
With annual research expenditures in excess of $100M, the University of Texas at Arlington is a Carnegie Research-1 “highest research activity” institution committed to life-enhancing discovery, innovative instruction, and caring community engagement. A leading institution in the heart of the thriving North Texas region, UTA nurtures minds within an environment that values excellence, ingenuity, and diversity. With a total global enrollment of over 59,000 in AY 2018-19, UTA is one of the largest institutions in the University of Texas System. Guided by its Strategic Plan Bold Solutions | Global Impact, UTA fosters interdisciplinary research and teaching to enable the sustainable megacity of the future within four broad themes: health and the human condition, sustainable urban communities, global environmental impact, and data-driven discovery. UTA was cited by U.S. News & World Report as having the second lowest average student debt among U.S. universities in 2018. U.S. News & World Report also ranks UTA fourth in the nation for undergraduate diversity. The University is a Hispanic-Serving Institution and is ranked as the top four-year college in Texas for veterans on Military Times’ 2018 Best for Vets list.