Senior Regulatory Associate, Surgery

UT Southwestern Medical Center • Dallas, TX

2d

About The Position

The Sr Regulatory Associate for the Department of Surgery's Surgical Partners in Research (SPAR) office supports the department's regulatory and compliance activities by conducting and providing oversight of coordinating, maintaining, and monitoring regulatory documentation and Institutional Review Board (IRB) submissions in accordance with applicable federal, state, institutional, and sponsor requirements. This role provides guidance and training for the department's regulatory associates, as well as collaborates closely with research sponsors, clinical research coordinators, and principal investigators to support regulatory processes across various studies such as medical device and drug studies. The ideal candidate demonstrates a strong interest and experience in clinical research and regulatory affairs, with particular enthusiasm for surgical, medical device, and pharmaceutical research. Prior clinical research coordination experience is highly valued.

Requirements

• Bachelor's Degree
• 3 years of related experience in review, oversight, or performance management of scientific research projects.
• May consider experience and education in lieu of requirements

Nice To Haves

• Advanced degree in health sciences field
• Previous service on an IRB or IACUC a plus.
• CERTIFIED PROFESSIONAL or Previous service on an IRB

Responsibilities

• Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators.
• Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.
• Maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects.
• Monitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.
• Recommends new policies and procedures for improvement of program compliance activities. Ensures compliance with applicable laws, regulations, policies, and procedures.
• Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
• Reads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research.
• Performs 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: Senior