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

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferences

• Previous UAB experience strongly preferred.