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 job is to work closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. 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 be primarily responsible for regulatory support of a specific Disease Oriented Team's (DOT) clinical trials 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 training.
• This position will also mentor the entry level and mid-level staff on the team as well as cover the regulatory support for the fast track program.
• Regulatory experience in Clinical Research strongly preferred.

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%25 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!