The department of Pharmacy Practice and Science is seeking qualified candidates for the position of Clinical Research Manager (II) at the R. Ken Coit College of Pharmacy, University of Arizona. The Clinical Research Manager (II) is responsible for regional program administration and daily operational oversight for observational and Clinical Trials in the R. Ken Coit College of Pharmacy. This position requires extensive expertise and daily working knowledge of clinical trial program compliance and regulatory requirements including IRB and audits. The Clinical Research Manager (II) is responsible for all programmatic aspects of clinical studies (interventional and observational) including staff on-boarding, training, data management, and documentation tracking. This person will direct an initial start-up team of 5-7 staff clinical research coordinators.
This position is eligible for a hybrid work schedule with at least 2 days in the office. Schedule is subject to change based on business needs.
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; state and optional retirement plans; access to UA recreation and cultural activities; and more!
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Duties & Responsibilities- Manage daily operations for Clinical Trials including hiring, training, scheduling, policy development and implementation, payroll and evaluation and managing performance while maintaining adherence to budget.
- Responsible for Direct research coordinators and other staff in the conduct of observational and interventional clinical studies related to aging and longevity in the R. Ken Coit College of Pharmacy.
- Plan and manage programmatic and operational start-up activities for new clinical trial and observational studies. Develops and directs innovative and strategic approaches for performing new types of studies from an operational standpoint.
- Facilitates communication with internal and external regulatory groups to ensure compliance of Clinical Trials for the college.
- Accountability to review specific budgets and contracts, monitor quality across all sites, develop training materials for clinical and administrative teams, develop reports & analytics that support key initiatives and strategies, develop and review SOPs, develop policies, support day to day operations and problem solve clinical and administrative situations.
- Direct periodic meetings to monitor on-going and new start-up Clinical Trials and observational studies. Communicate progress of Clinical Trials and direction from leadership to other parties, including communications with sponsoring entities and infrastructure support departments including compliance, quality, legal, regulatory and finance.
- Develop and maintain visual management system and datadashboards, including production/dissemination of monthly, quarterly, andannual reporting.
- Bachelor's degree or equivalent advanced learning attained through professional level experience required.
- Minimum of 5 years of related work experience specific to Clinical Trials and new trial start-ups, including 2 years of managerial experience, or equivalent combination of education and work experience.
- Previous experience managing and leading a multi-site clinical trail research network.