Regulatory Associate Senior, Pediatrics

UT Southwestern Medical Center • Dallas, TX

9d

About The Position

The purpose of this job is to work closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. Perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB or IACUC approvals.

The Regulatory Associate Senior prepares, submits, and revises IRB applications, study modifications, and continuous review of IRB submissions. This role works closely with external CROs, academic institutions, and other studies sponsors to prepare regulatory documents in support of timely IRB approvals. Experience with Performance Site Activation is preferred.

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
• Experience with Performance Site Activation is preferred.

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: Mid Level
• Number of Employees: 5,001-10,000 employees