Regulatory Coordinator I, University of Arizona Cancer Center (Multiple Positions)

This Regulatory Coordinator position will provide dedicated clinical trials administration support for ongoing and new developmental efforts in cancer clinical trials research. This position works closely with clinical faculty and their disease team. This selected candidate will have regular contact with the University of Arizona Human Subjects Protection Program (IRB), investigators, clinical research staff (nurses, data managers), clinical trials sponsors (e.g. private industry and national cooperative groups), and administrative staff. It is expected that this person will have or develop a knowledge base of the disease areas assigned and current management principles and will be able to serve in a consulting role to new faculty and staff regarding policies and procedures for clinical research.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to UA recreation and cultural activities; and more!

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• 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.
• Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects.

• Bachelor's degree or equivalent advanced learning attained through experience required.
• One (1) year of relevant work experience required.

• Previous experience with national cooperative group and private industry cancer clinical research.