CLINICAL RESEARCH REGULATORY COORDINATOR II

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. Maintain regulatory documentation including ICF, protocol, 1572, CV's, ML, IB, recruitment materials, submission forms, draft informed consents. Maintain/prepare FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). To serve as resource person or act as consultant within area of regulatory expertise.

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.
• 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.

Preferences

• Advanced knowledge of regulations related to clinical trials and retrospective IRBs.
• Basic knowledge of clinical trials.gov, consenting, and protocol review, and adverse and serious adverse event reporting.
• Ability to work independently, to make decisions, to interact with sponsors, regulatory authorities, and investigators.
• Ability to communicate effectively with physicians, sponsors, and other collaborators.

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 .