Regulatory Associate, Simmons Cancer Center

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

TRS Retirement

Paid Parental Leave

Tuition Reimbursement

Job summary

UT Southwestern Medical Center in Dallas seeks a Regulatory Associate to ensure compliance with federal regulations for human subjects research and animal care. You will review study protocols, draft consent forms, complete IRB/FDA submissions, and maintain regulatory documents.

The role includes supervising junior staff, guiding tasks, and supporting DOT clinical trials, with opportunities for training and career growth within a premier medical center.

Qualifications

• Bachelor's Degree or equivalent required.
• 2 years of related experience; may consider experience and education in lieu of requirements.

Responsibilities

• Review study protocols, consent documents, and related materials to ensure compliance with applicable requirements.
• Provide supervision and guidance to junior Regulatory Assistants, assign tasks, and review work for accuracy.
• Administer expedited and exempt review processes, including intake of protocols and assessment of review level for IRB/IACUC determinations.
• Provide guidance to investigators on IRB/IACUC submissions, study performance, and compliance documentation.
• Contribute to development or updates of IRB/IACUC guidance, procedures, forms, and QA activities.
• Perform other duties as assigned.

Skills

Regulatory knowledge

IRB/IACUC familiarity

Study protocol review

Documentation & recordkeeping

Education

Bachelor's Degree or equivalent

Job description

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 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. The Regulatory Associate 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.

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 Bachelor's Degree or equivalent

• Experience 2 years of related experience; May consider experience and education in lieu of requirements.

JOB DUTIES

• 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.

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 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.