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Form of workPOSITION INFORMATION: Provides senior administrative management to the Clinical Trials program by overseeing, training and developing the Clinical Trials Office (CTO) Regulatory Team. Provides professional-level support in evaluating business and operational practices to enhance the quality and delivery of services to the University. Supervises the CTO Regulatory team, ensures CTO processes follow regulatory requirements as set forth by governing agencies, develops strategies to raise awareness for regulatory processes, stays abreast of new industry practices, and acts as a liaison with other departments/organizations. Assists with preparation and production of the annual operating budget. ESSENTIAL DUTIES:
- Program Management. Provides direct administrative and fiscal management for Regulatory Affairs of the program(s) and related grants. Manages the day-to-day business operations of the program. Responsible for overseeing, planning, and monitoring of strategic plans. Manages and implements new workflows and processes to help improve collaboration within all CTO teams.
- Fiscal/Budget. Responsible for fiscal oversight and management to include decisions regarding appropriate rates within University approved salary ranges for new hires, appropriate increases and promotions for existing staff, and approval of purchases for the Regulatory team such as supplies and equipment. Responsible for financial planning of the program(s) and monitoring progress. Develops and manages the Regulatory team's budget. Ensures the fiscal viability of programs and advises college/department leadership on long-range financial planning and development of new initiatives.
- Assessment. Ensures staff correctly identifies clinical trial types and the initial assessment of appropriate start up activity to verify completeness, that all applicable trial documents are accurately reflected for the trial, and the consent forms for each study are approved, inclusive of federal, state and institutional required language. Responsible for conducting ongoing assessments of outreach and timelines to determine needed services, funds, and staffing.
- Information Distribution. Ensures clinic staff and other departments are made aware of new regulatory processes, workflows and standards. Networking with other cancer institutions and applicable research partners to learn and share best practices and improve internal processes.
- Clinical Resource. Builds and maintains community relationships with outside physicians, other health care organizations, and serves as referral resource for non-CTO staff and investigators. Ensures completion of all aspects of study start up, continuing review, and study close-out are complete from a regulatory perspective.
- Data Management. Manages Clinical Trials data and performs data analysis. Establishes and maintains reporting metrics and operational functions to leadership to help meet the institutional mission and objectives.
- Meeting Attendance. Attends and presents clinical trial and regulatory information at various meetings.
- Personnel Supervision. Supervises assigned staff to include hiring, training, scheduling workloads, evaluating, and terminating employees. Ensures all employees adhere to institutional policies and procedures while ensuring federal regulations are met.
- As Needed. Performs various duties as needed to successfully fulfill the function of the position.
