CLINICAL RESEARCH REGULATORY COORDINATOR II jobs in United States
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University of Alabama at Birmingham · 3 days ago

CLINICAL RESEARCH REGULATORY COORDINATOR II

The University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II to support the DOM Clinical Research Enterprise. This role involves preparing and maintaining regulatory documentation, assisting with IRB submissions, and serving as a resource in regulatory expertise.

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H1B Sponsor Likelynote

Responsibilities

To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms)
To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms
To draft informed consents
To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs)
To assist in drafting compliant advertisements
To serve as resource person or act as consultant within area of regulatory expertise
Performs other duties as assigned

Qualification

Regulatory documentationIRB submissionsFDA applicationsInformed consentsConsultation skills

Required

Bachelor's degree in a related field and three (3) years of related experience required
Work experience may substitute for education requirement

Preferred

Previous UAB experience strongly preferred

Company

University of Alabama at Birmingham

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The University of Alabama at Birmingham is a public university in located in Birmingham, Alabama.

H1B Sponsorship

University of Alabama at Birmingham 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 (373)
2024 (333)
2023 (214)
2022 (261)
2021 (155)
2020 (168)

Funding

Current Stage
Late Stage
Total Funding
$45.14M
Key Investors
American Academy of Orthopaedic SurgeonsParkinson's FoundationNational Institutes of Health
2023-12-01Grant· $0.02M
2023-07-25Grant
2023-06-26Grant

Leadership Team

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Martha Bidez
Professor and Director, Advanced Safety Engineering & Management
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