Regulatory Coordinator I, 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 and conduct. Participate in routine and end of study monitoring and auditing process for assigned studies to ensure compliance with policies, regulations, protocols, and SOPs. 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. Actively participate in assigned program area(s) by scheduling and preparing agendas and minutes for program area meetings. 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.