Senior Regulatory Associate, Surgery

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 Sr Regulatory Associate for the Department of Surgery's Surgical Partners in Research (SPAR) office supports the department's regulatory and compliance activities by conducting and providing oversight of coordinating, maintaining, and monitoring regulatory documentation and Institutional Review Board (IRB) submissions in accordance with applicable federal, state, institutional, and sponsor requirements. This role provides guidance and training for the department's regulatory associates, as well as collaborates closely with research sponsors, clinical research coordinators, and principal investigators to support regulatory processes across various studies such as medical device and drug studies. The ideal candidate demonstrates a strong interest and experience in clinical research and regulatory affairs, with particular enthusiasm for surgical, medical device, and pharmaceutical research. Prior clinical research coordination experience is highly valued.

 

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 
   

• Experience
  3 years of related experience in review, oversight, or performance management of scientific research projects. 
  May consider experience and education in lieu of requirements 
   

Preferred

• Education
  Advanced degree in health sciences field 
   

• Experience
  Previous service on an IRB or IACUC a plus. 
   

• Licenses and Certifications
  CERTIFIED PROFESSIONAL or
  Previous service on an IRB 
   

JOB DUTIES

• Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators.
• Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.
• Maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects.
• Monitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.
• Recommends new policies and procedures for improvement of program compliance activities. Ensure