Manager, Clinical Trials Administration

Manager, Clinical Trials Administration

The University of Arizona Health Sciences (UAHS) Office of Research Administration is looking for a Manager, Clinical Trials to work closely with colleagues in a fast-paced environment. This position will offer ample opportunity to work in the world of research administration in support of faculty who conduct research in the multiple colleges that comprise the University of Arizona Health Sciences. The position will work closely with faculty, research staff, study teams, and our medical partners including Banner Health, to coordinate clinical trial activities including the development of coverage analysis, budget negotiations, oversight of the Clinical Trial Management System (CTMS), regulatory support services, and clinical trials post award.

Research Administration, within the University of Arizona Health Sciences (UAHS), provides concierge-level service to all UAHS investigators in support of clinical research services. This is an exciting opportunity to work in a team environment with a strong customer service focus and to play a part in facilitating the groundbreaking research occurring every day at the University of Arizona. Forbes Magazine has named The University of Arizona as one of the state's best places to work in 2023!

This position is responsible for supervising assigned staff to proactively address the needs of clinical research administration by motivating and leading the team members to provide exceptional customer service and quality control to investigators. The University of Arizona Health Sciences (UAHS) Research Administration team is committed to identifying and adhering to best practices in clinical research administration while upholding high standards of integrity and fiduciary responsibility. They will oversee unit and individual assignments to team members, organize team meetings to share best practices and institutional processes, develop shared templates and tools, review and approve proposals within Health Sciences, and independently assist investigators with opening clinical research studies and timely start-up. The Manager will collaborate with investigators; sponsors; contract research organizations; central campus administrative units including the Sponsored Projects Services, Human and Clinical Research Compliance Services, and college and departmental business offices.

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

Duties & Responsibilities :

• Supervise UAHS Research Administration team comprised of highly skilled professionals that will support research endeavors across the Colleges of Medicine, Nursing, Public Health, and Pharmacy. Responsible for hiring, quality control, performance management and evaluation, development and training to ensure a collegial, high-functioning team aligned with team timeline goals and service standards that impact multiple colleges and their research objectives.
• Responsible for allocating resources including budget and staffing needs for various research projects impacting multiple colleges within Health Sciences.
• Establishes operating objectives for the unit and evaluates progress of unit against objectives for clinical trial administration services including coverage analysis development, trial budget development and negotiation, regulatory services support, oversight of the clinical trial management system (CTMS), and clinical trial post-award management to meet operational objectives.
• Ensure timely completion of coverage analyses and independently negotiates terms of research for clinical trial budgets and contract payment terms with internal and external stakeholders.
• Manage and facilitate contract amendments and related budget revisions.
• Oversee reconciliation of UAccess Analytics and UAccess Financial reports and data to departmental records. Review financial reports to ensure clinical trial budgets cover departmental costs.
• Oversee management of clinical trial study portfolios and collaborate with external medical partners and campus business units to ensure all billing is consistent with appropriate regulations, contractual obligations and internal documentation.
• Oversee regulatory service delivery in support of IRB paperwork preparation, data and safety monitoring plans, regulatory compliance, and protocol writing.
• Oversee management of CTMS including building study visits and financials for all UAHS clinical trials.
• Organize team meetings to share the best practices and institutional processes which impact all five colleges within the Health Sciences, development of shared templates and tools, ensuring timely submission and approval of clinical trial proposals in UAccess Research, and independent support for assigned investigators.
• Provide training, education and professional development to team, faculty and staff, including disseminating best practices and changes in clinical trial policies.
• Work closely with Sponsored Projects, Human Subjects Protection Program, and other partners on the implementation of new clinical research related policies and practices.
• Formulate, develop, implement and revise clinical trial budget and coverage analysis procedures and strategies. Promote standardization of clinical trial processes throughout UAHS.
• Maintain and report team and individual metrics through applicable systems.
• Facilitate audits of expenditures and reporting databases to ensure compliance with the regulatory, sponsor and university requirements.
• Self-motivated; takes initiative and strong ability to multi-task multiple projects and ensure numerous priorities and projects are accomplished concurrently.

Knowledge, Skills and Abilities :

Minimum Qualifications :

Preferred Qualifications :