This position is responsible for day-to-day administrative activities in support of the human subject research program at UT Arlington. Duties include support of the Institutional Review Board (IRB) and Regulatory Services Manager; pre-review of human subject research protocols to ensure compliance with applicable federal and state regulations, University policies, and IRB procedures; conducting protocol audits for compliance with the approved IRB protocol and applicable regulations and policies; assisting with noncompliance investigations and federal / sponsor reporting obligations; coordinating and facilitating reliance and/or reciprocity arrangements for collaborative human subject research projects; providing resources and education to researchers regarding the requirements and conduct of FDA-regulated research and clinical trials; maintenance of all required protocol and regulatory documentation, data entry, and records; and support of the campus-wide human subject protection outreach and training program.
Conducts comprehensive review of human subject research applications/protocols & study amendments to ensure compliance with applicable federal regulations, University policies, written IRB procedures, and industry best practices; appropriately classifies IRB submissions and identifies applicable regulatory requirements based upon funding sources, FDA requirements, regulatory criteria, and risks to subjects; provides written feedback and requests for revisions to researchers based on regulations for compliance and ethical research; conducts exemption determinations & internal Minimal Risk study approvals on behalf of the IRB; advises the IRB on protocol reviews and compliance issues. Provides excellent customer service and consistent, accurate written and verbal guidance to students, faculty, and staff regarding human subject research requirements and the UTAIRB submission process; answers researcher questions and offers individualized assistance for specific research projects through in-person meetings, phone calls, webinars, and emails. Oversees aspects of the University's central compliance requirements for biomedical studies & clinical trials, including general oversight of the University administrator accounts on ClinicalTrials.gov, SMARTIRB, and ResearchMatch.org; conducts Good Clinical Practice (GCP) audits & provides researcher education on FDA & GCP requirements; requests physician and/or pharmacist consultant reviews for clinical research studies; verifies FDA approval / clearance status for FDA-regulated drugs and medical devices used in IRB submissions; reviews federal grant applications for congruency with the IRB protocol; and checks researcher GCP training in CITI. Maintains a comprehensive list of collaborative research studies involving external institutions & non-UTA research sites; coordinates with other universities & hospital systems to facilitate IRB reliance arrangements for collaborative studies; ensures that institutional reliance and/or reciprocity is appropriately documented for studies where multiple institutions are engaged and relying on a Single IRB. Advises/supports Manager and Director in maintaining research program compliance and research integrity. Provides input to program improvement, policy updates, customer service, training, research collaborations, and compliance issues. Informs supervisors about protocol violations with OHRP, FDA, IRB. Assists in the conduct of IRB noncompliance investigations and with reporting noncompliance to federal agencies / sponsors per mandated reporting guidelines. Conducts day-to-day activities of the IRB (human research) program as assigned: coordinates committee meetings and follow-up; creates detailed minutes for committee meetings in accordance with regulatory requirements; maintains IRB-related recordkeeping; maintains a system of reminders to assist researchers in meeting annual review deadlines; prepares reports on IRB activities. Stays current with national best practices in human subject protection and research integrity. Supports a comprehensive campus outreach and education program to communicate regulatory requirements, university policies / procedures, and provide guidance on proper protocol preparation; assists Regulatory Manager in developing new training materials and in generating ideas for new educational content; delivers educational presentations to researchers in person and online using web conferencing technologies like Zoom; assists Regulatory Services Manager in maintaining up-to-date standard operating procedures and website content. Support and coordination with other areas of Regulatory Services including: animal subject research, bio-safety, export control, conflict of interest, responsible conduct of research, research misconduct. Coordinates with other departments on campus for research related activities such as accounting issues for human subject payments, engagement of University Legal for studies involving procedures subject to Texas state laws, coordination with IT / external consultants for development of electronic system, etc. Performs other duties as assigned.
Knowledge, Skills and Abilities: Experience with interpretation of federal and state regulations and implementation of clinical research programs or monitoring to meet regulatory requirements. Thorough understanding of Good Clinical Practices (GCP) standards and requirements for FDA-regulated human subjects research. Extremely effective time management and organization skills for dealing with constant and recurring deadlines. High ethical standards and values. Excellent written and verbal communication skills. Ability to establish and maintain effective working relationships with researchers, administrators, and others. Experience with information systems and familiarity with database and word processing software. Highly motivated with strong initiative to improve, update, and develop programs to meet user expectations and changing regulatory requirements/guidelines.
Bachelor’s degree in a related field. Minimum of two years of experience in clinical research ethics, compliance, or study coordination required. Experience with interpretation of federal regulations for the protection of human subjects in research and implementation of programs or monitoring to meet regulatory requirements.
A Master’s degree with a working knowledge and minimum of three years of experience in research ethics and compliance is preferred. Experience in research compliance in a higher education institution with a medical school or clinical program is highly desirable. CIP (Certified IRB Professional) or CCRP (Certified Clinical Research Associate) is preferred.
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: 8870
About University of Texas at Arlington
The University of Texas at Arlington sets the standard for educational excellence in the thriving Dallas-Fort Worth metropolitan area and is one of the nation’s fastest-growing public research universities. With an enrollment of 38,000 on-campus students and an additional 15,000 online degree-seeking students, UTA is the second-largest institution in The University of Texas System. The University offers more than 180 bachelor’s, master’s, and doctoral degrees through 10 colleges and schools and is rising in stature through its commitment to transforming the lives of students, pushing the boundaries of knowledge, and serving a growing and diverse community. UTA has developed a strategic plan, “Bold Solutions, Global Impact” (http://www.uta.edu/strategicplan). Taking advantage of our unique location at the center of the fastest growing urban region in the U.S. and adjacency to the Dallas-Fort Worth International Airport, our vision is to be ‘The Model 21st Century Urban Research University’. To support this vision, our strategic plan focuses on four over-arching themes across the University: Health and the Human Condition, Sustainable Urban Communities, Global Environmental Impact, ...Data Driven Discovery and Knowledge Management. The College of Engineering is playing a critical role in the advancement of each of these themes. Our highly ranked academic programs attract the best and brightest scholars from around the world, and our faculty and students consistently receive national and international recognition for their accomplishments. U.S. News & World Report ranks UT Arlington fifth among national universities for undergraduate diversity, we are a designated Hispanic Serving Institution, and the Military Times recently named UTA as the best 4-year College for veterans in the state of Texas. The Chronicle of Higher Education ranks UT Arlington among the 20 fastest-growing public research universities in the United States over the last 10 years. With a population of 7 million, the Dallas-Fort Worth Metroplex is the fourth-largest urban area in the United States. It covers an area larger than the states of Rhode Island and Connecticut combined. The Metroplex is the economic and cultural hub of North Texas and has the 10th-largest gross metropolitan product in the world. Not only is it an exciting place to live and work, the Metroplex offers UT Arlington a host of unparalleled scholarly, research, and economic activity. UTA has been a catalyst for redevelopment and revitalization in the central business district of Arlington, establishing a true college town environment in downtown Arlington. UTA’s 20-acre, mixed-use College Park District provides new special events and student living space, restaurants, and parking as part of its broad-based initiative to generate and support economic activity at the city’s urban center. In addition, the University is expanding its footprint in both Fort Worth and Dallas and has plans to increase its global presence building on active partnerships led by the College of Business and the College of Nursing and Health Innovation in Central and South America, South East Asia and the Middle East. For more information on University of Texas at Arlington, visit: www.uta.edu