Regulatory Associate

UT Southwestern Medical Center • Dallas, TX

2d • Onsite

About The Position

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 provides regulatory support for multiple clinical research studies within the Neuroscience Clinical Research Unit, with primary responsibility for study start-up and ongoing regulatory maintenance. This position coordinates the preparation, submission, tracking, and maintenance of regulatory documents, including Institutional Review Board (IRB) submissions, performance site reviews, and other required regulatory approvals, to facilitate the timely activation and conduct of clinical research studies. The Regulatory Associate manages multiple studies simultaneously while ensuring compliance with institutional, federal, and sponsor requirements. This position requires exceptional organizational, time management, and problem-solving skills to prioritize competing deadlines and maintain regulatory timelines. Strong written and verbal communication skills are essential, as the Regulatory Associate collaborates closely with investigators, study teams, institutional offices, sponsors, and external partners to support efficient study start-up and ongoing regulatory compliance.

Requirements

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

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level