CLINICAL RESEARCH REGULATORY COORDINATOR II
University of Alabama at Birmingham•University, MS
49d
About The Position
The University of Alabama at Birmingham (UAB), OB/GYN - Maternal & Fetal Medicine, is seeking a Clinical Research Regulatory Coordinator II.
Requirements
- Bachelor's degree in a related field and three (3) years of related experience required.
- Work experience may substitute for education requirement.
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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Educational Services
Number of Employees
5,001-10,000 employees
