UT Southwestern Medical Center · 1 day ago
Regulatory Specialist, Urology
Dallas, TX
Full-time
Onsite
Senior Level
7+ years expUT Southwestern Medical Center is a world-renowned medical and research center located in Dallas-Fort Worth, Texas. They are seeking a Regulatory Specialist for the Urology Department to provide full regulatory support, work closely with investigators on clinical trials, and ensure compliance with regulatory requirements.
Health CareHospitalMedical
Responsibilities
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
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
Qualification
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
Benefits
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
Company
UT Southwestern Medical Center
UT Southwestern Medical Center offers clinical care, education, and scientific research.
10001+ employees
H1B Sponsorship
UT Southwestern Medical Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (358)
2024 (238)
2023 (266)
2022 (274)
2021 (213)
2020 (179)
Funding
Current Stage
Late StageTotal Funding
$22MKey Investors
The Dallas FoundationPatient-Centered Outcomes Research Institute
2023-06-20Grant
2023-04-20Grant· $4M
2023-03-28Grant· $18M
Leadership Team
Chris Rubio
Interim Chief Executive Officer, Clements University Hospital
Dennis Pfeifer
AVP & CTO University Health System
Recent News
2025-12-26
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2025-12-24
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