CLINICAL RESEARCH REGULATORY COORDINATOR III

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR III (T233532) The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator III. 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: Please attach a current resume with this application. General Responsibilities Prepare and submit multiple levels of research documentation (IRB submissions, educational materials, reports, grant renewal reports, study forms). Prepare and maintain FDA applications for INDs and IDEs. Lead the implementation of study-specific regulatory processes of a moderate to complex nature. Conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams within clinical trial operations. Design and implement quality initiatives ensuring effective and efficient clinical processes. Write reports, business correspondence, and procedure manuals. Plan, develop, and present training; ensure research staff complete all requisite training; maintain appropriate licensure for clinicians. Serve as a mentor to junior regulatory staff; train others, provide constructive feedback. Serve as liaison with medical staff, University Departments, ancillary departments, satellite facilities, IRB, and sponsor contacts. Serve on various committees; stay active in relevant regional and national forums. Perform other duties as assigned. Annual Salary Range $55,180 - $89,670 Qualifications Bachelor's degree in a related field and 5 years of related experience required; work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred. Preferences Knowledge of ICH-GCP guidelines. IRB regulatory experience, FDA knowledge. Critical thinking skills. Problem-solving skills across a wide variety of clinical studies. Expert knowledge of related scientific and clinical terminology. Ability to work independently as well as within a team. Prioritization skills. Organizational skills. Process improvement and quality skills. Written and verbal communication skills. Prefer a health, science, or business administration degree. 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. Primary Location University Job Category Clinical Research Employee Status Regular Shift: Day/1st Shift Work Arrangement (final schedule to be determined by the department/hiring manager): Remote/Hybrid Eligible #J-18808-Ljbffr