Regulatory Associate, Surgery

Regulatory Associate, Surgery (942191) Regulatory Associate for the Department of Surgery’s Surgical Partners in Research (SPAR) office supports regulatory and compliance activities by coordinating, maintaining, and monitoring regulatory documentation and IRB submissions in accordance with applicable federal, state, institutional, and sponsor requirements. This role collaborates closely with research sponsors, clinical research coordinators, and principal investigators to support regulatory processes across various studies such as medical device and drug studies. Job Summary The Regulatory Associate plays a key role in supporting regulatory readiness, study lifecycle activities, and adherence to quality and compliance standards. The ideal candidate demonstrates a strong interest in clinical research and regulatory affairs, particularly for surgical, medical device, and pharmaceutical research. Prior clinical research experience is highly valued. Benefits PPO medical plan, available day one at no cost for full‑time employee-only coverage Paid Time Off, available day one Retirement Programs through the Teacher Retirement System of Texas (TRS) Paid Parental Leave Benefit Wellness programs Tuition Reimbursement Public Service Loan Forgiveness (PSLF) Qualified Employer Education & Experience Education – Bachelor’s Degree or equivalent Experience – 2 years of related experience; may consider experience and education in lieu of requirements Job Duties Review study protocols, informed consent documents, responses to stipulations, and other study‑related documentation to assure conformance with all applicable requirements. Provide working supervision, training, and guidance to lower‑level Regulatory Assistants; assign tasks and set work priorities; review work for accuracy. Administer expedited and exempt research review processes, including intake of protocols and assessment of review level, referral to full IRB/IACUC when applicable, and drafting correspondence to investigators regarding determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance; serve as an information resource about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures and business processes, related forms, database improvements, and other quality assurance activities. Perform other duties as assigned. Security and EEO Statement Security This position is security‑sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. EEO UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal‑opportunity employer, UT Southwestern prohibits unlawful discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. #J-18808-Ljbffr The University of Texas Southwestern Medical Center