What are the responsibilities and job description for the CLINICAL RESEARCH REGULATORY COORDINATOR II position at University of Alabama at Birmingham?
The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of clinical research documentation for the Dermatology Clinical Research Unit.
General Responsibilities
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
IRB clinical research experience.
Primary Location
University
Job Category
Clinical Research
Organization
311150000 Dermatology
Employee Status
Regular
Shift
Day/1st Shift
Work Arrangement (final schedule to be determined by the department/hiring manager)
Hybrid Eligible
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.
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
IRB clinical research experience.
Primary Location
University
Job Category
Clinical Research
Organization
311150000 Dermatology
Employee Status
Regular
Shift
Day/1st Shift
Work Arrangement (final schedule to be determined by the department/hiring manager)
Hybrid Eligible
Salary : $47,665 - $77,455