University of Alabama at Birmingham
CLINICAL RESEARCH REGULATORY COORDINATOR II (3)
University of Alabama at Birmingham, University, Florida, United States
Overview
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator II to prepare, submit, and assist with multiple levels of research documentation, IRB submissions to UAB, WIRB, Advarra, and others. The O'Neal Comprehensive Cancer Center is an NCI-designated center that supports cutting-edge cancer care and research. The department supports more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and employs more than 160 staff and physicians engaged in cancer patient care.
Please attach a current resume with this application.
Responsibilities
To prepare, submit, and assist with multiple levels of research documentation (e.g., 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 a resource person or act as a consultant within the area of regulatory expertise.
Maintains regulatory documentation including ICFs, protocols, 1572s, CVs, ML, IBs, recruitment materials, submission forms, and draft informed consents.
Maintains/prepares FDA applications for INDs and IDEs.
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 the education requirement.
Preferences
Advanced knowledge in regulatory aspects related to clinical trials and retrospective IRBs.
Basic knowledge of ClinicalTrials.gov, consenting, protocol review, and adverse event reporting.
Ability to work independently, make decisions, and interact with sponsors, regulatory authorities, and investigators.
Ability to communicate effectively with physicians, sponsors and other collaborators.
Additional Details
Annual Salary Range: $47,665 - $77,455
Primary Location: University
Job Category: Clinical Research
Organization: O'Neal Comprehensive Cancer Center
Employee Status: Regular
Shift: Day / 1st Shift
Work Arrangement: Hybrid Eligible
Equal Opportunity 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.
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Please attach a current resume with this application.
Responsibilities
To prepare, submit, and assist with multiple levels of research documentation (e.g., 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 a resource person or act as a consultant within the area of regulatory expertise.
Maintains regulatory documentation including ICFs, protocols, 1572s, CVs, ML, IBs, recruitment materials, submission forms, and draft informed consents.
Maintains/prepares FDA applications for INDs and IDEs.
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 the education requirement.
Preferences
Advanced knowledge in regulatory aspects related to clinical trials and retrospective IRBs.
Basic knowledge of ClinicalTrials.gov, consenting, protocol review, and adverse event reporting.
Ability to work independently, make decisions, and interact with sponsors, regulatory authorities, and investigators.
Ability to communicate effectively with physicians, sponsors and other collaborators.
Additional Details
Annual Salary Range: $47,665 - $77,455
Primary Location: University
Job Category: Clinical Research
Organization: O'Neal Comprehensive Cancer Center
Employee Status: Regular
Shift: Day / 1st Shift
Work Arrangement: Hybrid Eligible
Equal Opportunity 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.
#J-18808-Ljbffr