Regulatory Analyst, Human Research Protection

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

PPO health plan

Paid time off

Retirement program

Parental leave

Wellness programs

Tuition reimbursement

Public Service Loan Forgiveness

Employee benefits

Job summary

The University of Texas Southwestern Medical Center is seeking a Regulatory Analyst, Human Research Protection 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, you will perform thorough protocol pre-review in advance of submission to the IRB or IACUC and provide technical consultation on regulatory, scientific, or policy issues that affect IRB/IACUC

Qualifications

• Bachelor's or Master's degree in a related field required.
• Advanced science degree strongly preferred.

Responsibilities

• For campus-wide research, perform thorough protocol pre-review prior to IRB/IACUC submission and provide technical consultation on regulatory, scientific, or policy issues.
• Collaborate with IRB/IACUC and other regulatory entities to provide optimal protocol review services.
• Direct, analyze, coordinate, and evaluate research program operation and procedures.
• Develop and maintain relationships with internal/external departments and organizations involved with the research program.
• Set program goals, direct clinical trials program evaluation, and establish schedules, priorities, and standards.
• Recommend new policies and procedures for program improvement.
• Ensure internal controls are designed and effective; ensure operations are compliant with laws and policies.
• Stay updated on regulatory, scientific, and technical developments related to oversight of research.
• Perform other duties as assigned.

Education

Bachelor's Degree in related field

Master's Degree in related field

Job description

Job Description - Regulatory Analyst, Human Research Protection (939629)

Job Description

Regulatory Analyst, Human Research Protection - ( 939629 )

WHY UT SOUTHWESTERN?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY

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.

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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education Bachelor's Degree in related field or Master's Degree in related field

• Experience 3 years related experience with Bachelor's degree. or 1 year related experience with Master's degree.

Preferred

• Education Advanced science degree and extensive current knowledge of regulations governing human or animal research protections strongly preferred.

• Experience Previous service on an IRB or IACUC a plus.

JOB DUTIES

• 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.

SECURITY AND EEO STATEMENT

Security

This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.