Regulatory Assistant, Simmons Cancer Center

University of Texas Southwestern Medical Center
parental leave, paid time off, paid holidays, tuition reimbursement
United States, Texas, Dallas
5323 Harry Hines Boulevard (Show on map)
Feb 21, 2025
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 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. The individual 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. BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: 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! EXPERIENCE AND EDUCATION Required Education High School Diploma or GED Experience 4 years of related experience May consider education in lieu of experience. JOB DUTIES 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 PIs 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 PIs 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. 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. 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 Statement 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. Benefits UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: 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!