Regulatory Analyst, IACUC

UT Southwestern Medical Center•Dallas, TX

About The Position

The Regulatory Analyst works closely with investigators and research personnel to develop and refine proposals for human clinical trials or animal research. For campus-wide research, the role performs thorough protocol pre-review before submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provides Principal Investigators with technical consultation on regulatory, scientific, and policy matters that may affect approval likelihood. The position collaborates with the IRB, IACUC, and other institutional regulatory entities to support protocol review. It directs, analyzes, coordinates, and evaluates research program operations and procedures; maintains relationships with relevant internal and external groups; and establishes program goals, objectives, schedules, priorities, and standards. The role also supports program evaluation and quality control, recommends policy and procedural improvements, develops and maintains internal controls, ensures compliance with applicable requirements, and keeps current with relevant scientific, regulatory, and technical developments.

Requirements

Bachelor's degree in a related field and 3 years of related experience, or a master's degree in a related field and 1 year of related experience.
Excellent verbal, written, and interpersonal communication skills for working with staff, faculty, and scientists at all levels.
Ability to read, write, analyze data, develop plans and procedures, and coordinate resources to accomplish goals.
Ability to provide technical assistance and consultation to physicians and other scientists.
Ability to review, recommend, develop, and implement policies.
Computer proficiency and comfort with electronic technology for data management.

Nice To Haves

An advanced science degree and extensive current knowledge of regulations governing human or animal research protections are strongly preferred.
Previous service on an IRB or IACUC is a plus.

Responsibilities

Pre-review research protocols before submission to the IRB or IACUC and advise Principal Investigators on regulatory, scientific, or policy issues that may affect approval.
Collaborate with the IRB, IACUC, and other institutional regulatory entities to provide protocol review services to investigators.
Direct, analyze, coordinate, and evaluate research program operations and procedures.
Develop and maintain working relationships with internal and external departments, agencies, and organizations associated with or benefiting from the research program.
Establish research program goals and objectives; direct clinical trials program evaluation and quality-control activities; and develop or approve schedules, priorities, and standards.
Recommend new policies and procedures to improve program activities.
Design, execute, and assess internal controls that provide reasonable assurance of effective and efficient operations.
Ensure compliance with applicable laws, regulations, policies, and procedures.
Read literature and attend training and other functions to stay current with relevant scientific, regulatory, and technical developments related to research oversight.
Perform other duties as assigned.

Benefits

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 benefit.
Wellness programs.
Tuition reimbursement.
Public Service Loan Forgiveness (PSLF) qualified employer.
Paid holidays.
On-site childcare.
Wage and merit increases.