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Sr. Regulatory Associate - Human Research Protection at UT Southwestern Medical Center

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: Dallas, Texas

Job Description:

Full/Part Time/PRN: Day Job
Regular/Temporary: Regular
Schedule: Full-time


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


Salary Negotiable

Bachelor's degree required. Advanced degree in health sciences field preferred. Minimum three (3) yrs of related experience in review, oversight, or performance mgmt. of scientific research projects. Knowledge of regulations governing human subj. protection or animal care/use strongly preferred. Previous service on an IRB/IACUC a plus.

Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators.
Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.
Maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects.
Monitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.
Recommends new policies and procedures for improvement of program compliance activities. Ensures compliance with applicable laws, regulations, policies, and procedures.
Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
Reads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research.
Performs other duties as assigned.

This position is responsible for providing Quality Assurance and monitoring support to the HRPP. In addition to monitoring compliance of IRB-approved studies, this position will be responsible for assisting with the monitoring the quality of the IRB determinations and the documentation for the IRB meetings and determinations as required by regulation.

**Other Duties: Performs other duties as assigned.

UTSouthwestern 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; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UTSouthwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.