Regulatory Assistant, Urology

UT Southwestern Medical Center • Dallas, TX

10d

About The Position

Works under direct supervision to assist management with administrative and/or business functions to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies multiple regulations to complex scientific research projects.

Requirements

• High School Diploma or equivalent.
• 4 years of related experience.
• May consider higher education in lieu of experience.

Responsibilities

• Review Modification requests, as well as associated study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements. Seek consultation from IRB/IACUC Chairs and communicate determinations to PIs and research staff. Manage information in database and produce related reports as required.
• Review Adverse Event reports to assure conformance with all applicable requirements. Seek consultation from IRB/IACUC Chairs, as necessary, and communicate determinations to PIs and staff. Manage adverse event information in database and produce related reports as required.
• Provide consultation and technical assistance to investigators and study personnel regarding requirements for Modification and/or Adverse Event 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.
• Provide administrative support for IRB/IACUC Coordinators, including, but not limited to: managing reviews for expedited studies; preparing approval packets including approval letters, stamping and copying study documents and notifying study personnel of completion; processing full-board study continuing review submissions, including review of submissions for completeness; data entry; communication with study personnel for clarifications or to request missing documents; and preparing assignment of studies to appropriate board or committee.
• Monitor automatic continuing review reminders on a daily basis, prepare and send study lapse letters.
• Assist with 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%25 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: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees