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); pre-review of research protocols to provide guidance to investigators; exemption determinations for qualifying studies; assisting with preparation for IRB meetings; preparing and distributing protocols for committee review; maintenance of all required documentation, data entry, and records; and support of the campus-wide IRB outreach and training program.
1. Conducts comprehensive review of human subject research applications/protocols to ensure compliance with federal regulations, university policies, and best practices; provides feedback, guidance, and revisions to researchers via written and verbal communication based on regulations for compliance and ethical research; advises the IRB on protocol reviews and compliance issues. Conducts exempt / minimal risk determinations on behalf of the IRB. 2. Meets with researchers in person and over the phone to provide guidance in preparing IRB protocols. Provides excellent and timely customer service to researchers throughout the UTA community. 3. Conducts day-to-day activities of the IRB (human research) program as assigned; coordinates committee meetings; maintains IRB-related recordkeeping and prepares meeting minutes; prepares internal reports; conducts protocol audits and monitoring. 4. Advises/supports Manager and Director in maintaining research program compliance, research integrity, and customer service. Provides input to program improvement, customer service, training, research collaborations, and compliance issues. Informs supervisors about violations with OHRP, FDA, IRB. 5. Maintains up-to-date standard operating procedures and website content; makes recommendations for policy updates. Stays current with national best practices in human subject protection and research integrity. Creates communications to stakeholders for changes and updates. 6. Creates and presents educational content to faculty, staff, and students via seminars, workshops, and IRB mini-conferences. 7. Coordinates with other departments on campus and/or other universities/entities for research related activities such as research collaborations, accounting issues for human subject payments, coordination with IT for development of electronic system, etc. 8. Support and coordination with other areas of Regulatory Services including: animal subject research, biosafety, export control, conflict of interest, responsible conduct of research, research misconduct.
Bachelor’s degree in a related field or the equivalent experience. Experience with interpretation of federal and state regulations and maintaining programs or monitoring to meet regulatory requirements.
A Master’s degree with a working knowledge and minimum of two years of experience in research ethics and compliance is preferred. Experience in research compliance in a higher education institution is highly desirable. Experience with academic or biomedical research, federal grants, and/or Good Clinical Practice is beneficial. Experience with operations of human subjects protection program is preferred. CIP (Certified IRB Professional) certification is preferred.