The University of Alabama at Birmingham (UAB), Department of DOM Research Unit, is seeking a Clinical Research Regulatory Coordinator II. This position will support the DOM Clinical Research Enterprise.

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