Regulatory Analyst, IACUC

UT Southwestern; Dallas (TX); On-site; USD 75,000 - 125,000; Full time

Benefits offered by this job

PPO medical plan day one

Paid Time Off

Tuition Reimbursement

Parental Leave Benefit

Wellness programs

Public Service Loan Forgiveness (PSLF)

Job summary

UT Southwestern Medical Center in Dallas, TX is seeking a regulatory affairs professional to work with investigators on human clinical trials and animal research proposals. You will conduct thorough protocol pre-reviews before IRB/IACUC submissions and provide expert consultation on regulatory, scientific, or policy issues affecting approvals.

The role emphasizes collaboration with IRB/IACUC and other regulatory bodies, ensuring compliance, developing program goals, and advancing research

Qualifications

• Requires Bachelor's degree in a related field; Master's preferred.
• 3 years related experience with Bachelor's degree or 1 year with Master's degree.
• Advanced science degree and strong knowledge of regulations governing human or animal research protections preferred.
• Previous service on an IRB or IACUC is a plus.

Responsibilities

• Perform thorough protocol pre-review for IRB/IACUC submissions and provide technical consultation to Principal Investigators on regulatory, scientific, or policy issues affecting approvals.
• Collaborate closely with IRB/IACUC and other regulatory entities to provide optimal protocol review services.
• Directs, analyzes, coordinates, and evaluates research program operation and procedures.
• Develops working relationships with internal/external departments and organizations related to the research program.
• Establishes research program goals and directs clinical trials program evaluation and quality control activities; sets schedules and standards.
• Recommends new policies and procedures to improve program activities.
• Ensures internal controls and compliance with laws, regulations, policies, and procedures.
• Keeps abreast of scientific, regulatory, and technical developments relevant to research oversight.
• Performs other duties as assigned.

Skills

Communication

Written communication

Interpersonal skills

Data analysis

Regulatory knowledge

Policy development

Education

Bachelor's Degree in related field

Master's Degree in related field

Job description

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 No. 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

UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• 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.

Knowledge, Skills and Abilities

• Work requires excellent verbal, written, and interpersonal communication skills to work effectively with all levels of staff, faculty, and scientists.
• Work requires ability to read, write, analyze data, develop plans and procedures, and coordinate resources to accomplish goals.
• Work requires ability to provide technical assistance and consultation to physicians and other scientists.
• Work requires responsibility for review, recommendation, development, and implementation of policies.
• Work requires computer proficiency and comfort with electronic technology for data management.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

Working Conditions

• Office Setting

Salary Information

Salary is commensurate with education, skills, and relevant experience.

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.