Regulatory Associate, Neurosurgery

Regulatory Associate – Neurosurgery Department  

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 patients and employees. With over 20,000 employees, we are committed to continuing our growth with the best professionals in the healthcare industry. We invite you to be a part of the UT Southwestern team where you’ll discover teamwork, professionalism, and consistent opportunities for growth.

Departmental Job Description

The Neurosurgery department is looking to hire a full time Regulatory Associate to assist with ongoing clinical research studies. This position will work directly with the Neurosurgery research team and Principal Investigators to assist in the preparation, submission, and regulatory/compliance guidance for FDA submissions, single-IRB management, and additional regulatory oversight as needed.    

Experience and Education        

• Bachelor’s degree, or equivalent, and two (2) years of related experience required.

• May consider experience and education in lieu of requirements.        

Job Duties

• Works under limited supervision to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies ethical principles and multiple regulations to complex scientific research projects.

• 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.   

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

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. 

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