University of Alabama at Birmingham
CLINICAL RESEARCH REGULATORY COORDINATOR II
University of Alabama at Birmingham, Birmingham, Alabama, United States, 35275
CLINICAL RESEARCH REGULATORY COORDINATOR II
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.
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.
Qualifications
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.
Annual Salary Range Annual Salary Range:
$47,665 - $77,455
Details
Primary Location: University
Job Category: Clinical Research
Organization: 311400030 DOM Research Unit
Employee Status: Regular
Shift: Day/1st Shift
Work Arrangement: Onsite
Equal Opportunity Statement UAB is an Equal Employment/Equal Educational Opportunity Institution 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, and veteran’s status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB’s Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
Other
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Higher Education
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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.
Qualifications
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.
Annual Salary Range Annual Salary Range:
$47,665 - $77,455
Details
Primary Location: University
Job Category: Clinical Research
Organization: 311400030 DOM Research Unit
Employee Status: Regular
Shift: Day/1st Shift
Work Arrangement: Onsite
Equal Opportunity Statement UAB is an Equal Employment/Equal Educational Opportunity Institution 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, and veteran’s status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB’s Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
Other
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Higher Education
#J-18808-Ljbffr