IRB/IACUC Regulatory Analyst — Human Research Protection

UT Southwestern Medical Center

Dallas (TX)

On-site

USD 90,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Healthcare benefits

Paid time off

On-site childcare

Retirement programs

Job summary

UT Southwestern Medical Center in Dallas is seeking a regulatory professional to support development and refinement of proposals for human clinical trials or animal research. You will perform protocol pre-reviews, provide technical consultation on regulatory issues, and collaborate with IRB/IACUC to ensure approvals.

The role requires advanced knowledge of research protections, familiarity with IRB/IACUC processes, and prior service with IRB/IACUC is a plus.

Qualifications

Bachelor's Degree in related field or
Master's Degree in related field
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 IRB or 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.