Regulatory Associate Senior, Simmons Cancer Center

Why UT Southwestern? With over 75 years of excellence in Dallas‑Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world‑renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas‑Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on‑site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! Job Summary The purpose of this role is to work closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. The incumbent will perform thorough protocol pre‑review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB or IACUC approvals. The Regulatory Associate Senior will primarily support a specific Disease Oriented Team’s (DOT) clinical trials, while also providing backup for other DOTs as needed. Responsibilities include reviewing study protocols, drafting consent forms, completing IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintaining essential regulatory documents both electronic and paper, and preparing and facilitating the DOT studies for long‑term storage at Iron Mountain. The role also involves ancillary services such as maintaining CTEP IDs for physicians, staff regulatory training, mentoring entry‑ and mid‑level staff, and covering regulatory support for the fast‑track program. Responsibilities Collaborate closely with the IRB, IACUC, and other regulatory entities to provide optimal protocol review services for investigators. Prepare, submit, and revise all IRB or IACUC applications, including renewal and audit reports. Maintain working relationships with internal and external departments, agencies, and other organizations associated with research projects. Monitor and evaluate research project quality‑control activities and train personnel on IRB, IACUC, HIPAA compliance, and information security protocols. Recommend new policies and procedures to improve program compliance activities; ensure compliance with applicable laws, regulations, policies, and procedures. Design, execute, and maintain a system of internal controls that provide reasonable assurance of effective and efficient operations. Stay current with relevant scientific, regulatory, and technical developments related to oversight of clinical research through literature review, training, and other functions. Perform other duties as assigned. Qualifications Bachelor’s degree. Three years of related experience in review, oversight, or performance management of scientific research projects. Preferred Advanced degree in a health sciences field. Previous service on an IRB or IACUC. Certified professional or other relevant certifications. Benefits PPO medical plan, available day one at no cost for full‑time employee‑only coverage. 100% coverage for preventive healthcare – no copay. 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. 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, including 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. Location Texas – Dallas – 5323 Harry Hines Blvd #J-18808-Ljbffr UT Southwestern Medical Center