What are the responsibilities and job description for the CLINICAL RESEARCH REGULATORY COORDINATOR II position at University of Alabama at Birmingham?
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator II.
The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https://www.uab.edu/onealcancercenter/
Please attach a current resume with this application.
General Responsibilities
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
Organization
310008400 Comprehensive Cancer Center
Employee Status
Regular
Shift
Day/1st Shift
Work Arrangement (final schedule to be determined by the department/hiring manager)
Onsite
The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https://www.uab.edu/onealcancercenter/
Please attach a current resume with this application.
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.
- Prepares, submits, and assists with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Maintains regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
- Drafts informed consents.
- Prepares and maintains FDA applications for INDs and IDEs.
- Assists in drafting compliant advertisements.
- Makes and assists in modifying protocols and study documents.
- Completes and submits safety Reports and government documents as needed.
- Enters protocol-specific data into required institutional systems (IRAP, OnCore, and RedCap).
- Maintains appropriate licensure for clinicians.
- Conducts internal quality assurance audits of regulatory files.
- Oversees maintenance of Delegation of Authority logs.
- Maintains the study's compliance with institutional requirements.
- Assists colleagues in identifying efficiencies and improving processes.
- Serves as a mentor to junior regulatory staff. May train others in various work responsibilities and provide constructive feedback.
- Performs other duties as assigned.
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
- Strong understanding of clinical trial operations, regulatory processes, OnCore, and RedCap data systems.
- Exceptional communication, organizational, and leadership skills.
Organization
310008400 Comprehensive Cancer Center
Employee Status
Regular
Shift
Day/1st Shift
Work Arrangement (final schedule to be determined by the department/hiring manager)
Onsite
Salary : $47,665 - $77,455