University of Alabama at Birmingham · 7 hours ago
CLINICAL RESEARCH REGULATORY COORDINATOR III
Greater Birmingham, Alabama Area
Full-time
Hybrid
Mid, Senior Level
$55K/yr - $90K/yr
5+ years expThe University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator III. This role is responsible for ensuring compliance with regulatory standards throughout clinical trials, including the preparation and submission of various research documentation and conducting quality assurance audits.
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Responsibilities
To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms)
To prepares and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs)
To lead the implementation of study specific regulatory processes of a moderate to complex nature
To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations
To design and implement quality initiatives ensuring effective and efficient clinical processes
Audits Investigator Initiated Trials (IIT), Cooperative trials, and pharmaceutical-sponsored trials
Conducts internal quality assurance audits of regulatory files
Assists in the design and implementation of quality initiatives, ensuring effective and efficient clinical processes
Verifies compliance with protocols, Standard Operating Procedures (SOPs), FDA, ICH, and GCP regulations
Maintains Quality Assurance 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 Quality Assurance 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 Evaluate 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
Five (5) years of related experience
Work experience may NOT substitute for education requirement
Preferred
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification
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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