Clinical Research Operations Manager

The Clinical Research Operations Manager will direct the day-to-day operations of the NIH funded RECOVER Initiative (long COVID research) at the University of Arizona, a regional hub site, and operationalize numerous clinical and research procedures through partnerships with various medical teams. This position requires extensive clinical knowledge with critical thinking skills, as well as expertise of clinical trial program compliance to ensure high quality data completion and regulatory management. The successful candidate will function in a dynamic, highly matrixed dyad management structure with multiple principal investigators across the State of Arizona. They will lead a collaborative team of research professionals including, study coordinators, research nurses, data analysts, project managers and support personnel, with a long term focus to facilitate future funding opportunities and grow a portfolio of trials to address the epidemic of long COVID.

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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• Direct regional program administration and daily operational oversight of clinical research network for Long COVID patients, initially RECOVER observational study, affiliated RECOVER Clinical Trials and, new clinical trials sponsored in conjunction with Aegis.
• Operationalize study specific clinical procedures ensuring subject safety, accurate data completion and reporting, and regulatory compliance.
• Accountability to review specific budgets and contracts, monitor quality across all sites.
• Develop training materials for clinical and administrative teams.
• Generate reports & analytics that support key initiatives and strategies.
• Create and review SOPs.
• Support day to day operations and problem solve clinical and administrative situations, including direct supervision of program staff.
• Direct meetings to monitor on-going and new start-up studies and related communications with sponsoring entities, PI's and infrastructure.
• Support departments including compliance, quality, legal, regulatory and finance.
• Develop and maintain study network visual management system and data dashboards, including production/dissemination of monthly, quarterly and annual reporting.
• Develop annual growth plan with overall responsibility to achieve all targets, milestones and metrics for patient enrollments in all clinical research trials including each new clinical trial.
• Manage all outreach efforts and initiatives to ensure successful program growth.
• Share responsibility with highly matrixed program team PI's to secure new, additional clinical trials to grow the clinical trial research network.
• Provide primary accountability for all programmatic and operational start-up activities for each new clinical trial.
• Develop and direct innovative and strategic approaches for performing new types of studies from a technical research and operational standpoint.

Knowledge, Skills, and Abilities (KSAs):

• Critical thinking/decision making expertise in a healthcare setting.
• Skilled in leading a multi-disciplinary, highly matrixed team, project, program, or function in a research and/or clinical arena.
• Ability to manage research operations that includes interfacing with healthcare systems and managing financial aspects of research and/or clinical operations

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Seven (7) years of related work experience, including three (3) years of managerial experience, or equivalent combination of education and work experience.

• Ten (10) years of related work experience specific to clinical trials and new trial start-ups.
• Prior experience managing and leading a multi-site clinical research network.
• Registered nurse.