UT Southwestern has an opening for the position of Regulatory Analyst for the Office of Human Research Protection
The Regulatory Analyst will perform protocol pre-review prior to submission to the IRB. Provide consultation to PI on regulatory, scientific, or policy issues. Collaborate with IRB and other regulatory entities at the institution to provide optimal protocol review services for PIs. Directs, analyzes, coordinates, and evaluates research program operation and procedures. Develop, cultivate, and maintain working relationships with internal/external departments/agencies associated with and/or receiving benefit from the research program. Establish research program goals and objectives. Recommend new policies/procedures for improvement of program activities. Responsible for design, execution, and effectiveness of system of internal controls. Ensures compliance with applicable laws, regulations, policies, and procedures. Reads literature and attends training as necessary.
- Bachelor’s degree in related field and three (3) years related research experience is required.
- 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.
- 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 & 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.
- Work is performed primarily in general office area.
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
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. To learn more, please visit: https://jobs.utsouthwestern.edu/why-work-here/diversity-inclusion/.