T219995 - University of Alabama at Birmingham
Birmingham, AL
About the Job
The University of Alabama at Birmingham (UAB), Department of DOM Research Unit, is seeking a Clinical Research Regulatory Coordinator II.This positionwill 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:%2447,665 - %2477,455
Bachelor's degree in a related field and three (3) years of related experience required.Work experience may substitute for education requirement.
The University of Alabama at Birmingham (UAB) is an Equal Employment/Equal Educational Opportunity Institution. UAB is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, religion, sexual orientation, gender identity, gender expression, and veteranrsquo;s status. Title IX of the Educational Amendments of 1972 protects individuals from discrimination based on sex in any educational program or activity operated by recipients of federal financial assistance. As required by Title IX, UAB does not discriminate based on sex in its educational programs or activities, including in admission and employment. Inquiries concerning the application of Title IX may be referred to UABrsquo;s Assistant Vice President and Senior Title IX Coordinator, the U.S. Department of Educationrsquo;s Office for Civil Rights, or both. UABrsquo;s Assistant Vice President and Senior Title IX Coordinator is Andrea McDew, 701 20th Street South, Suite 1030, Birmingham, AL 35233, 205-934-5493, amcdew@uab.edu.
University311400030 DOM Research UnitRegular