Regulatory Associate, Simmons Cancer Center

Regulatory Associate, Simmons Comprehensive Cancer Center – Cancer Research

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. As the only National Cancer Institute-designated comprehensive cancer center in North Texas, we invite you to continue your healthcare career with us at Harold C. Simmons Comprehensive Cancer Center. You’ll discover a magnet facility with a culture of teamwork, professionalism, and consistent opportunities for learning and advancement into leadership roles.

Job Summary

Join UT Southwestern as a Regulatory Associate (RA) in Simmons Comprehensive Cancer Center Education and Training Office for cancer research. As a RA at UT Southwestern, you will have the opportunity to join a team of the top cancer specialists in the country and be a part of our innovative therapies, cutting-edge research, and life changing clinical trials. As a valued team member, you will be responsible for regulatory support of a specific Disease Oriented Team\’s (DOT) clinical trials under the leadership of the Cancer Center Associate Director of Clinical Research as well as provide support and backup for other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents both electronic and paper, and preparing and facilitating the DOT studies for long term storage at Iron Mountain. In addition, each regulatory team member provides ancillary services such as assisting with and maintaining the CTEP IDs for physicians as well as staff regulatory trainings.

Experience and Education

Minimum Requirements

• Bachelor’s degree, or equivalent and two (2) years of related experience required.
• May consider additional education in lieu of experience.

Job Duties 

• Works under limited supervision to assure compliance with federal regulations relating to human subject research and/or animal care and use.
• Understands and applies ethical principles and multiple regulations to complex scientific research projects.
• Review study protocols, informed consent documents, response 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, but not limited to intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC 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 to the campus about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities.
• Perform other duties as assigned. 

To learn more about the benefits UT Southwestern offers visit https://www.utsouthwestern.edu/employees/hr-resources/ 

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.