CLINICAL RESEARCH REGULATORY COORDINATOR III

CLINICAL RESEARCH REGULATORY COORDINATOR III (T236395) Position: Clinical Research Regulatory Coordinator III at the University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center. Responsibilities include preparing, writing, reporting, and following up on Serious Adverse Events (SAE), CAPA, and deviations, preparing regulatory documentation, managing FDA applications, leading study-specific regulatory processes, conducting internal quality assurance audits, and designing quality initiatives. General Responsibilities Prepare and submit multiple levels of research documentation (IRB submissions, educational materials, reports, grant renewal reports, and study forms). Prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). Lead implementation of study-specific regulatory processes of moderate to complex nature. Conduct internal QA audits of regulatory files, programs, reports, and teams within clinical trial operations. Design and implement quality initiatives to ensure effective and efficient clinical processes. Write reports, business correspondence, and procedure manuals. Plan, develop, and present training. Develop and oversee implementation of Standard Operating Procedures (SOPs) when needed. Improve processes as needed. Serve as mentor to junior regulatory staff and provide constructive feedback. Act as liaison with medical staff, university departments, ancillary departments, satellite facilities, IRB, and sponsor contacts. Ensure research staff complete requisite training and maintain appropriate licensure for clinicians. Serve on various committees and remain active in relevant regional and national forums. Perform other duties as assigned. Qualifications Bachelor's degree in a related field and five (5) years of related experience. Work experience does NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred. Preferences Health, science, or business administration degree. Strong writing skills and preparation of regulatory documents. Knowledge of ICH‑GCP guidelines. IRB regulatory experience and FDA knowledge. Critical thinking and problem‑solving skills across diverse clinical studies. Expert knowledge of related scientific and clinical terminology. Ability to work independently and within a team. Prioritization, organizational, process improvement and quality skills. Annual Salary Range $55,180 – $89,670 Equal Employment Opportunity 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, genetic information, age, disability, and veteran's status. UAB prohibits sex discrimination in any educational program or activity it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. 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 Onsite #J-18808-Ljbffr