UT Southwestern Medical Center · 2 weeks ago
Regulatory Monitoring Analyst, Office of Research Regulatory Affairs
Dallas, TX
Full-time
Hybrid
Senior Level
5+ years expUT Southwestern Medical Center is a world-renowned medical and research center committed to excellence and innovation. The Regulatory Monitoring Analyst role involves conducting clinical research monitoring, auditing, and regulatory reporting tasks, ensuring compliance with federal regulations and guidelines.
Health CareHospitalMedical
Responsibilities
Conducts complex assurance/effectiveness reviews of compliance activities in accordance with appropriate standards, metrics, established compliance plan(s) and prescribed departmental/unit/program policies
Develops monitoring plan tools for use in assessment, and the sampling methodologies and solutions to implement post monitoring in the respective area (research team and research offices)
Evaluates effectiveness of research regulatory/compliance controls used by reviewed department/unit/program, as well as adherence with all applicable university research policies and procedures. Develops metrics within respective areas of Research Administration for evaluating effectiveness of controls and operational areas
Creates monitoring reports with supporting evidence, and defends findings and recommendations made regarding identified regulatory or procedural deficiencies that may affect research compliance
Assists Vice President for Research Administration and Research Administration Directors in investigations of alleged breaches of policy, misconduct or other acts of non-compliance to determine cause, extent of loss and mechanisms for prevention
Assists Vice President for Research Administration and Research Administration Directors in responding to audit findings identified by Internal Audit and external agencies
Assists with export control reviews referred to Research Administration
Maintains effective working relationships with Research Administration and compliance personnel to achieve objectives of assurance-related assignments, including coordination with the Research Compliance Officer and Research Compliance Committee to ensure operational activities integrate with institutional compliance activities
Remains abreast of current developments and topics in research administration and research regulatory compliance, and coordinates with respective areas of Research Administration to disseminate information
Works with respective areas of Research Administration to coordinate and maintain policies and procedures, and to maintain compliance-related education and training materials. Develops and conducts training sessions on compliance-related topics for research administrative areas, as needed
Performs other duties, as assigned
Qualification
Required
Bachelor's Degree in business, healthcare administration, or related area
5 years professional experience in compliance or regulatory affairs, with research monitoring or auditing activities
Experience at an academic medical center leading multi-faceted project teams, and developing and successfully implementing work plans based on risk-analysis
Preferred
Experience in pharmaceutical/biomedical industry or contract research organization or academic medical center conducting clinical research monitoring/compliance reviews
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
Medical Xpress - latest medical and health news stories
2025-12-24
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