Regulatory Associate, Temporary

UT Southwestern Medical Center•Dallas, TX

52d•Hybrid

About The Position

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. This is a full-time temporary assignment expected to last at least 3 months. The assignment will be primarily remote, with onsite presentation as needed to complete job duties.

Requirements

Bachelor's Degree or equivalent
2 years of related experience
May consider experience and education in lieu of requirements.
Work requires effective oral and written communication skills
Work requires project management and multi-tasking skills
Work requires knowledge of regulations governing human subject protection and/or animal care and use
Work requires strong customer service skills
Work requires knowledge of medial terminology and ability to provide technical assistance and guidance
Work requires computer proficiency for data management and electronic submissions
Work requires ability to work in a team-oriented setting

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.
Various administrative and clerical assignments filled on an as needed basis.