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.