Regulatory Analyst, Human Research Protection

Job Summary

The purpose of this job is to work closely with investigators and research personnel on the development and refinement of proposals for the performance of human clinical trials or animal research. For campus‑wide research, 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/IACUC approvals.

UT Southwestern offers a competitive comprehensive benefits package designed to support overall wellbeing, including:

• 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

Required

• Education – Bachelor's Degree in related field or Master's Degree in related field
• Experience – 3 years related experience with Bachelor's degree or 1 year related experience with Master's degree

Preferred

• Advanced science degree and extensive current knowledge of regulations governing human or animal research protections strongly preferred
• Previous service on an IRB or IACUC a plus

• For campus‑wide research, perform thorough protocol pre‑review in advance of submission to the IRB or IACUC and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB/IACUC approvals
• Collaborate closely with the IRB or IACUC and other regulatory entities at the institution to provide optimal protocol review services for investigators
• Direct, analyze, coordinate, and evaluate research program operation and procedures
• Develop, cultivate, and maintain working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program
• Establish research program goals and objectives; direct clinical trials program evaluation and quality control activities; develop and/or approve schedules, priorities and standards for achieving goals
• Recommend new policies and procedures for improvement of program activities
• Responsible for design, execution and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient
• Ensure compliance with applicable laws, regulations, policies and procedures
• Read literature and attend training and other functions as necessary to keep abreast of relevant scientific, regulatory and technical developments related to oversight of research
• Perform other duties as assigned

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 – UT Southwestern Medical Center is a committed equal‑opportunity employer. The University prohibits unlawful discrimination, including harassment, on the basis of race, color, religion, national origin, gender (including sexual orientation), age, disability, citizenship, veteran status, genetic information, and in accordance with federal and state law. Discrimination based on sexual orientation, gender identity, or gender expression is also prohibited.