CLINICAL RESEARCH REGULATORY COORDINATOR II
UAB Medicine
Description
The University of Alabama at Birmingham (UAB), DOM Research Unit is seeking a Clinical Research Regulatory Coordinator II. This position will support the DOM Clinical Research Enterprise and its shared services.
General 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.
Annual Salary Range: $47,665 - $77,455
Qualifications
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Previous UAB experience strongly preferred.