Senior Regulatory Associate, Surgery jobs in United States
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UT Southwestern Medical Center · 15 hours ago

Senior Regulatory Associate, Surgery

UT Southwestern Medical Center is a world-renowned medical and research center in Dallas-Fort Worth, Texas, committed to excellence and innovation. The Senior Regulatory Associate will collaborate with regulatory entities to provide protocol review services, maintain compliance, and ensure the effectiveness of internal controls related to clinical research projects.

Clinical TrialsHealth CareHospitalMedicalNon ProfitOncologyOutpatient Care
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H1B Sponsor Likelynote

Responsibilities

Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators
Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports
Maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects
Monitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols
Recommends new policies and procedures for improvement of program compliance activities. Ensures compliance with applicable laws, regulations, policies, and procedures
Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient
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

IRB complianceIACUC complianceHIPAA complianceScientific research oversightQuality control activitiesProtocol review servicesTraining personnelPolicy recommendationInternal controls design

Required

Education Bachelor's Degree
Experience 3 years of related experience in review, oversight, or performance management of scientific research projects

Preferred

Education Advanced degree in health sciences field
Experience Previous service on an IRB or IACUC a plus
Licenses and Certifications CERTIFIED PROFESSIONAL or Previous service on an IRB

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

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UT Southwestern Medical Center offers clinical care, education, and scientific research.

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 Stage
Total Funding
$22M
Key Investors
The Dallas FoundationPatient-Centered Outcomes Research Institute
2023-06-20Grant
2023-04-20Grant· $4M
2023-03-28Grant· $18M

Leadership Team

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Chris Rubio
Interim Chief Executive Officer, Clements University Hospital
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Dennis Pfeifer
AVP & CTO University Health System
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