University of Alabama at Birmingham · 2 months ago
CLINICAL RESEARCH QUALITY COORDINATOR
Greater Birmingham, Alabama Area
Full-time
Hybrid
Mid Level
$50K/yr - $81K/yr
3+ years expThe University of Alabama at Birmingham (UAB) is seeking a Clinical Research Quality Coordinator to ensure the quality and regulatory compliance of clinical research activities. This role involves monitoring and auditing quality assurance processes and providing guidance to research teams to adhere to institutional and federal requirements.
EducationHealth CareUniversities
Responsibilities
To ensure the quality and regulatory compliance of clinical research activities assigned to studies or programs
To support the monitoring and auditing of quality assurance processes and provide guidance to research teams to ensure adherence to institutional and federal requirements
Provides ongoing remote clinical monitoring assistance to study sites
Provides ongoing monitoring and review of safety reporting as follows, but not limited to: review of all adverse events documented by site CRAs into the study database/eDES. Review of all reporting of SAE via eDES, Medwatch Report Forum, and Pharmaceutical documents, and provide assistance as needed
Safety reporting to Sponsor, Protocol Chair, Protocol Team, Operations Center PI, Medical Monitor, DSMB, Study sites, and other protocol-designated agencies into eDES, along with email prompts for delinquent data entries
Provides monitoring review of all newly screened and potential study participants
Provides ongoing protocol training/support to clinical sites
Monitors and reviews all central evaluations and sends evaluations to study sites and summarizes protocol requirements as needed
Collects all external IND safety reports
Obtains Operations Center Pl's written acknowledgement
Obtains Protocol Chair's written acknowledgement
Maintains a safety log of all received safety reports and specifies when protocol and/or consent document changes are required
Shares all external IND safety reports with clinic study sites after obtaining the Protocol Chair's written acknowledgement
Places all external IND safety report email communication to clinical sites into eDES study-specific docs section folder
Works with the regulatory specialist whenever changes to the informed consent document are required. Plexiform QOL review and site queries
Reviews of diary drug compliance documents generate queries when necessary. NF Consortium email requests for assistance (potential subjects). Protocol Reviews participate in all protocol reviews and editing if needed. Travel to sites/travel expected 1 to 2 times per month for an average of 1-2 days per monitoring visit or 1 week per month
Follows the QAC Guidelines for site monitoring. Remote Monitoring - since COVID, remote monitoring
Provides recommendations of notes to files, provides documentation, and is available for internal audits
Handles protocol clinical queries by sites and delinquent queries to the site for missing data
Reports to the QAC Chair as appropriate
Drug accountability, maintenance, and compliance overall study and final study reports
Coordinates with Pharmacy for drug compliance. Keep up-to-date database clinical records
Performs other duties as assigned
Qualification
Required
Bachelor's degree in a related field
Three (3) years of related experience
Work experience may substitute for education requirement
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
Company data provided by crunchbase