Regulatory Associate, Neurosurgery

UT Southwestern Medical Center • Dallas, TX

12d

About The Position

The Department of Neurological Surgery is seeking a Regulatory Associate to join its central research team, the Neurosurgery Research Group (NRG). The Regulatory Associate will oversee the regulatory compliance of NRG’s diverse clinical research portfolio, including investigator-initiated trials, NIH-funded studies, FDA IDE trials, industry-sponsored drug and device trials, and sIRB studies where we serve as the IRB of record.

Requirements

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

Nice To Haves

• Previous experience with Central IRB Applications
• Previous Experience with Local IRB Submissions
• Previous experience with eFlorence or a similar physical or electronic regulatory binder maintenance
• Previous experience with FDA applications and amendments
• Previous Performance Site Review Experience

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%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: Mid Level
• Number of Employees: 5,001-10,000 employees