CLINICAL RESEARCH REGULATORY COORDINATOR II
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.
- Previous UAB experience strongly preferred.
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