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CLINICAL RESEARCH REGULATORY COORDINATOR II

University of Alabama, Birmingham

Details

Posted: 20-Sep-24

Location: Birmingham, Alabama

Type: Full-time

Salary: Open

Internal Number: T219995

CLINICAL RESEARCH REGULATORY COORDINATOR II - (T219995)

Description

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

Qualifications

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 veteran'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 UAB's Assistant Vice President and Senior Title IX Coordinator, the U.S. Department of Education's Office for Civil Rights, or both. UAB'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.

Primary Location

: University

Job Category

: Clinical Research

Organization

: 311400030 DOM Research Unit

Employee Status

: Regular

Shift: Day/1st Shift

Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite

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About University of Alabama, Birmingham

Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with more than $715 million in annual research funding and an economic impact on the state exceeding $12.1 billion a year. UAB is Alabama’s largest employer, with some 28,000 employees, and was named Forbes’ No. 1 Large Employer in the United States in 2021. UAB enrollment surpassed 21,500 for the fifth consecutive year in fall 2022. The university offers more than 180 degree programs in nine schools and one college. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement and patient care. Learn more at www.uab.edu.

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