ScholarLink Inc. is hiring: CLINICAL RESEARCH REGULATORY COORDINATOR II in Birmingham

ABOUT THE POSITION
The Clinical Research Regulatory Coordinator II position at the University of Alabama at Birmingham involves overseeing regulatory compliance for clinical research projects, including IRB applications, FDA submissions, and maintaining regulatory documentation.
The role requires knowledge of federal regulations, human subjects protections, and strong project management skills.
RESEARCH INTERESTS
• Prepare, submit, and track IRB applications and amendments
• Maintain regulatory documentation including consent forms, protocols, CVs, licenses
• Draft informed consents and assist with FDA applications (INDs, IDEs)
• Assist in drafting compliant advertisements
• Serve as resource or consultant in regulatory area
• Conduct QA audits for regulatory files
REQUIRED SKILLS & QUALIFICATIONS
• Knowledge of federal regulations (HIPAA, FDA, OHRP)
• Experience with IRB submission processes
• Proficiency with electronic databases (MURE, IRAP, Veeva Vault, Florence e-binder)
BUILD A STATEMENT OF PURPOSE
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