UT Southwestern Medical Center · 10 hours ago
Senior Regulatory Analyst, Human Research Protection
5323 Harry Hines Blvd5323 Harry Hines Blvd
Full-time
Onsite
Senior Level
5+ years expUT Southwestern Medical Center is a world-renowned medical and research center committed to excellence, innovation, teamwork, and compassion. The Senior Regulatory Analyst will work closely with investigators and research personnel to develop and refine proposals for human clinical trials or animal research, ensuring compliance with regulatory standards and providing technical consultation to Principal Investigators.
Clinical TrialsHealth CareHospitalMedicalNon ProfitOncologyOutpatient Care
Responsibilities
For campus-wide research, provide expert-level knowledge (application and interpretation) of federal regulations (DHHS, PHS, FDA, USDA, HIPAA, etc.), state regulations and policies, and institutional policies relevant to human or animal research and privacy. These include research related policies of UTSW
Review complicated scientific research documents and identify substantive ethical and regulatory issues as well as institutional policy issues
May approve protocol submissions eligible for expedited/designated member review
Document the decision making process as required by federal regulations in applicable reviewer checklists, database and correspondence
Provide guidance to research committee staff, board members/chairs and researchers on resolving complex and controversial issues
Solve, recommend and implements solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the regulatory review process
Directs, analyzes, coordinates, and evaluates research committee operation and procedures. Capture and document in the minutes controverted ethical and scientific issues identified during the review process. Summarize judgments/resolution of issues for each item of review
Reads literature and attends training and other functions as necessary to keep current on changes to regulations and consider implications for institutional review processes
Provide education and training to faculty and study staff, HRPP/IACUC Office staff and Board members related to the protocol review process and develop and distribute resource materials in an effort to improve protections for research subjects
Responsible for preparing, sending and tracking incident notifications to researchers, institutional leadership and federal officials as required by federal regulations (i.e., FDA, USDA, HHS, PHS, DOD, DOE, etc.)
Respond to follow-up inquiries by federal agencies, faculty, and officials from affiliated institutions regarding notifications from the research committee
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 committee goals and objectives and directs research committee evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals
Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient
Performs other duties as assigned
Qualification
Required
Bachelor's Degree in related field
5 years of related research experience with Bachelor's degree or 3 years of related research experience with Master's degree
Preferred
Master's Degree Advanced science degree strongly
Previous service on an Institutional Review Board or Institutional Animal Care and Use Committee (IACUC) a plus
(CPIA) CERT PROF IN IACUC ADMINISTRTN or CIP or extensive current knowledge of regulations governing human or animal research protections strongly preferred
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
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