Regulatory Associate Senior, Simmons Cancer Center

About the Role

This position works closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. The Regulatory Associate Senior performs thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provides technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB or IACUC approvals.

The primary responsibility is regulatory support of a specific Disease Oriented Team's (DOT) clinical trials, as well as providing support and backup for other DOTs as needed. The regulatory team reviews study protocols, drafts consent forms, completes IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintains essential regulatory documents both electronic and paper, and prepares and facilitates DOT studies for long-term storage. Additionally, this role mentors entry-level and mid-level staff, covers regulatory support for the fast-track program, and assists with maintaining CTEP IDs for physicians and staff regulatory training.

Responsibilities

• Collaborates closely with the IRB, IACUC, and other regulatory entities to provide optimal protocol review services for investigators.
• Prepares, submits, and revises all IRB or IACUC applications, including renewal and audit reports.
• Maintains working relationships with internal/external departments/agencies and other organizations associated with 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 internal controls to provide reasonable assurance that operations are effective and efficient.
• Stays abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research through literature and training.
• Performs other duties as assigned.

Requirements

• Bachelor's Degree.
• 3 years of related experience in review, oversight, or performance management of scientific research projects.

Preferred Qualifications

• Advanced degree in a health sciences field.
• Previous service on an IRB or IACUC.
• Certified Professional certification or equivalent experience.

Benefits

UT Southwestern offers a competitive and comprehensive benefits package, including:

• PPO medical plan, available day one at no cost for full-time employee-only coverage (100% coverage for preventive healthcare with no copay).
• Paid Time Off, available day one.
• Retirement Programs through the Teacher Retirement System of Texas (TRS).
• Paid Parental Leave.
• Wellness programs.
• Tuition Reimbursement.
• Public Service Loan Forgiveness (PSLF) qualification.

Location: Dallas, Texas (5323 Harry Hines Blvd). Full-time, day shift.