CLINICAL RESEARCH REGULATORY COORDINATOR II

CLINICAL RESEARCH REGULATORY COORDINATOR II (T235996) The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator II. Overview 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. 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. Link to website: Key Responsibilities Prepare, submit, and assist with multiple levels of research documentation (e.g., IRB submissions, educational materials, reports, grant renewal reports, and study forms). Maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. Draft informed consents. Prepare and maintain FDA applications for INDs and IDEs. Assist in drafting compliant advertisements. Serve as resource person or consultant within regulatory expertise. Modify protocols and study documents as needed. Complete and submit safety reports and government documents. Enter protocol‑specific data into required institutional systems (IRAP, OnCore, and RedCap). Maintain appropriate licensure for clinicians. Conduct internal quality assurance audits of regulatory files. Oversee maintenance of Delegation of Authority logs. Maintain study compliance with institutional requirements. Assist colleagues in identifying efficiencies and improving processes. Serve as a mentor to junior regulatory staff; may train others and provide constructive feedback. Perform 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 Strong understanding of clinical trial operations, regulatory processes, OnCore, and RedCap data systems. Exceptional communication, organizational, and leadership skills. EEO 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. Location and Work Arrangement Primary Location: University Job Category: Clinical Research Employee Status: Regular Shift: Day/1st Shift Work Arrangement: Onsite #J-18808-Ljbffr University of Alabama at Birmingham