University of Alabama at Birmingham · 2 months ago
CLINICAL RESEARCH REGULATORY COORDINATOR II (2)
Greater Birmingham, Alabama Area
Full-time
Onsite
Mid Level
$48K/yr - $77K/yr
3+ years expThe University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II. This role involves ensuring compliance with regulatory standards throughout clinical trials and maintaining essential documentation for quality assurance and regulatory compliance.
EducationHealth CareUniversities
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
Verifies compliance with protocols, Standard Operating Procedures (SOPs), FDA, ICH and GCP regulations
Maintains QA data files
Prepares accurate audit reports, makes recommendations for corrective actions with input/review from Director Quality Management
Assists with follow-up on sponsor and internal audit queries. Including assisting with the writing of Corrective and Preventive Actions (CAPA) when applicable
Escalates and presents major findings to the Director of Quality Management
Identifies needed training programs for clinical research staff based upon quality assurance review and reports. Including but not limited to ALCOA, source documentation completion, and overall QA process training
Responsible for Quality Management and preparation of study-related material for FDA, EMA, and Sponsor audits with assistance as necessary
When applicable, participates in pre-study meetings as QA representative
Evaluates and presents Quality Assurance findings/metrics to appropriate staff members and managers
Performs other duties as assigned
Qualification
Required
Bachelor's degree in a related field and three (3) years of related experience required
Work experience may substitute for education requirement
Preferred
Knowledge of ICH-GCP guidelines
Accuracy, thoroughness, and attention to detail are imperative
Skilled in maintaining/reviewing records
Skilled in developing and maintaining effective working relationships with staff
Ability to work independently as well as within a team
Ability to communicate effectively with peers, physicians, and management both orally and in written form
Must be self-directed/self-motivated
Skill in time management and executing workload with minimal supervision
Company
University of Alabama at Birmingham
The University of Alabama at Birmingham is a public university in located in Birmingham, Alabama.
10001+ employees
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 StageTotal Funding
$45.14MKey Investors
American Academy of Orthopaedic SurgeonsParkinson's FoundationNational Institutes of Health
2023-12-01Grant· $0.02M
2023-07-25Grant
2023-06-26Grant
Leadership Team
Martha Bidez
Professor and Director, Advanced Safety Engineering & Management
Recent News
2025-12-03
2025-11-27
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