Senior Regulatory Associate, Simmons Cancer Center

Senior Regulatory Associate – Simmons Cancer Center

Why UT Southwestern? With over 75 years of excellence in Dallas‑Fort Worth, 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.

Join UT Southwestern as a Senior Regulatory Associate (RA) in the Simmons Comprehensive Cancer Center Education and Training Office for cancer research. In this role, you will provide regulatory support for a specific Disease‑Oriented Team’s (Use the "Apply for this Job" box below). trials under the leadership of the Cancer Center Associate Director of Clinical Research, and provide support and backup for other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, submit IRB and/or FDA documentation (initial, modifications/amendments, continuing reviews, and study closure), maintain essential regulatory documents both electronically and in paper, and facilitate the long‑term storage of DOT studies at Iron Mountain.

Additionally, each regulatory team member assists with and maintains the CTEP IDs for physicians, staff regulatory trainings, and mentors entry‑ and mid‑level staff.

• 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
• Learn more about these and other UTSW employee benefits!

• Bachelor’s degree
• At least 3 years of related experience in review, oversight, or performance management of scientific research projects

• Advanced degree in a health sciences field
• Previous service on an IRB or IACUC
• Certification or previous service on an IRB

• Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators
• Prepares, submits, and revises all IRB or IACUC applications and renewal and audit reports
• Maintains working relationships with internal and external departments, agencies, and other organizations associated with associated research projects
• Monitors and evaluates research project quality control activities and trains personnel on IRB, IACUC, HIPAA compliance, and information security protocols
• Recommends new policies and procedures for improvement of program compliance activities and ensures compliance with applicable laws, regulations, policies, and procedures
• Responsible for design, execution, and effectiveness of a system of internal controls that provide reasonable assurance that operations are effective and efficient
• Reads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research
• Performs other duties as assigned

This position is security‑sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

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.

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Location:

5323 Harry Hines Blvd, Dallas, TX

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