Regulatory Associate, Neuroscience jobs in United States
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UT Southwestern Medical Center · 3 days ago

Regulatory Associate, Neuroscience

UT Southwestern Medical Center is a world-renowned medical and research center located in Dallas-Fort Worth, Texas. They are seeking a Regulatory Associate to oversee the regulatory compliance of the Neurosurgery Research Group's clinical research portfolio, which includes various types of clinical trials.

Clinical TrialsHealth CareHospitalMedicalNon ProfitOncologyOutpatient Care
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H1B Sponsor Likelynote

Responsibilities

Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements
Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy
Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations
Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use
Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities
Perform other duties as assigned

Qualification

Regulatory complianceIRB submissionsFDA applicationsClinical researchEFlorenceTeamworkCommunication

Required

Education Bachelor's Degree or equivalent
Experience 2 years of related experience

Preferred

Previous experience with Central IRB Applications
Previous Experience with Local IRB Submissions
Previous experience with eFlorence or a similar physical or electronic regulatory binder maintenance
Previous experience with FDA applications and amendments
Previous Performance Site Review Experience

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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Company data provided by crunchbase