Regulatory Specialist – Urology Department

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
This position will provide full regulatory support to the Department of Urology which has approximately 36 faculty.   This position will work closely with investigators and research personnel on the development and refinement of proposals for the performance of human clinical trials.  Perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issue that will affect the likelihood of IRB approvals.   

The employee will be expected to perform the below job duties along with the duties listed in the “Job Duties” section:

·        Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.

·        Responsible for the review and initial start-up of budgets

·        Monitors and evaluates research project quality control activities.

·        Ensure all regulatory requirements are met and make recommendations as needed

·        Provide training to employees on regulatory requirements and compliance procedures

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 
   

• Experience
  7 years of job-related experience in development, review, oversight, or performance management of human clinical trials. 
   

Preferred

• Education
  Master’s Degree in health sciences field. 
   

• Experience
  Previous service on an Institutional Review Board a plus. 
   

JOB DUTIES

• Collaborates closely with the IRB and other regulatory entities at the institution to provide optimal protocol review services for investigators.
• Directs, analyzes, coordinates, and evaluates clinical trials 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 clinical trials program.
• Establishes clinical trials 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 clinical 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.