Regulatory Analyst, Human Research Protection

University of Texas Southwestern Medical CenterDallas, TX
47d

About The Position

The purpose of this job is to work closely with investigators and research personnel on the development and refinement of proposals for the performance of human clinical trials or animal research. For campus-wide research, 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/IACUC approvals.

Requirements

  • Bachelor's Degree in related field or
  • Master's Degree in related field
  • 3 years related experience with Bachelor's degree. or
  • 1 year related experience with Master's degree.

Nice To Haves

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

Responsibilities

  • For campus-wide research, 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/IACUC approvals.
  • Collaborates closely with the IRB or IACUC and other regulatory entities at the institution to provide optimal protocol review services for investigators.
  • Directs, analyzes, coordinates, and evaluates research program operation and procedures.
  • Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program.
  • Establishes research program goals and objectives and directs clinical trials program evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals.
  • Recommends new policies and procedures for improvement of program activities.
  • Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
  • Ensures compliance with applicable laws, regulations, policies, and procedures.
  • Reads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of research.
  • Performs 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-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

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Educational Services

Number of Employees

5,001-10,000 employees

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