Regulatory Associate, Surgery

UT Southwestern Medical Center
Dallas, TX
Category Research
Job Description
The Regulatory Associate for the Department of Surgery's Surgical Partners in Research (SPAR) office supports the department's regulatory and compliance activities by coordinating, maintaining, and monitoring regulatory documentation and Institutional Review Board (IRB) submissions in accordance with applicable federal, state, institutional, and sponsor requirements.

Requirements

  • Bachelor's Degree or equivalent
  • 2 years of related experience
  • 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.
  • Administer expedited and exempt research review processes, including 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
  • 100% coverage for preventive healthcare-no copay
  • Paid Time Off
  • 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
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