Regulatory Coordinator II, Cancer Center (Full-Time)

Prepare and/or coordinate IRB and other required submissions and approvals of new phase I-III and other protocols for industry, investigator-initiated, and national cooperative group studies in assigned program area(s). Prepare and/or coordinate IRB and other required submissions of protocol amendments and other revisions, IND safety reports, and progress reports for approval for assigned studies. Coordinate other regulatory activities pertaining to clinical trial start-up. Conduct compliance reviews, end-of-study monitoring, and audit activities for assigned studies to verify adherence to institutional policies, federal regulations, and study-specific protocols and SOPs. Support new employees by demonstrating proper work practices, adhering to established institutional process policy. Prepare, coordinate, and maintain regulatory compliance and related documentation required by regulatory agencies and sponsors. Update the clinical trials management system (CTMS) with respect to study status and actions. Provide regulatory advice and training on routine items to colleagues in assigned program area(s). Actively participate in assigned program area(s) by scheduling and preparing agendas and minutes for program area meetings. On an as-needed basis, review routine submissions and other assignments for quality assurance. Participate in the development and implementation of procedures and processes within the regulatory office. Assist in drafting and editing regulatory instructional materials. Other duties as assigned. Knowledge, Skills, and Abilities: Excellent technical writing skills. Demonstrated strong interpersonal, communication, and problem-solving skills. Excellent organizational skills. Knowledge of MS Word (word processing) and Excel. Knowledge of medical oncology terminology and treatment concepts. Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects. Previous experience with national cooperative group and private industry cancer clinical research.