Regulatory Associate, Simmons Cancer Center

UT Southwestern Medical Center • Dallas, TX

9h • Onsite

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. The Regulatory Associate will be primarily responsible for regulatory support of a specific Disease Oriented Team's (DOT) clinical trials as well as provide support and backup for other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents both electronic and paper, and preparing and facilitating the DOT studies for long term storage at Iron Mountain. In addition, each regulatory team member provides ancillary services such as assisting with and maintaining the CTEP IDs for physicians as well as staff regulatory training.

Requirements

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

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