Regulatory Associate, Neuroscience

Job Description - Regulatory Associate, Neurosurgery Department (918281)

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!

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.

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 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
• Education
  Bachelor's Degree or equivalent
• Experience
  2 years of related experience (may consider experience and education in lieu of requirements)

• 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

• 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.

Security:
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO: UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.

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