Regulatory Assistant, 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 Assistant at the Simmons Cancer Center. As a Regulatory Assistant, you will be primarily 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

• High School graduate or GED and four (4) years of related experience required.
• May consider education in lieu of experience. 

Job Duties

• Works under direct supervision to assist management with administrative and/or business functions to assure compliance with federal regulations relating to human subject research and/or animal care and use.
• Understands and applies multiple regulations to complex scientific research projects.
• Review Modification requests, as well as associated study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements.
• Seek consultation from IRB/IACUC Chairs and communicate determinations to PI's and research staff.
• Manage information in database and produce related reports as required Review Adverse Event reports to assure conformance with all applicable requirements.
• Seek consultation from IRB/IACUC Chairs, as necessary, and communicate determinations to PI's and staff.
• Manage adverse event information in database and produce related reports as required.
• Provide consultation and technical assistance to investigators and study personnel regarding requirements for Modification and/or Adverse Event 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.
• Provide administrative support for IRB/IACUC Coordinators, including, but not limited to: managing reviews for expedited studies; preparing approval packets including approval letters, stamping and copying study documents and notifying study personnel of completion; processing full-board study continuing review submissions, including review of submissions for completeness; data entry; communication with study personnel for clarifications or to request missing documents; and preparing assignment of studies to appropriate board or committee.
• Monitor automatic continuing review reminders on a daily basis, prepare and send study lapse letters.
• Complete study closures through ERGO. Assist with 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/

For general COVID-19 information, applicants should visit https://www.utsouthwestern.edu/covid-19/work-on-campus/ 

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. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.