Pre-Award Clinical Trial Management
• Lead clinical trial negotiations with industry sponsors, with support from the Principal Investigator and Assistant Director and assistance from clinical research coordinators.
• Oversee the preparation of IRB applications and maintain regulatory and IRB approvals throughout the project lifecycle and serve as a resource for the clinical research coordinators during their completion of the IRB process
• Prepare financial analysis for proposed clinical trials to ensure financial viability of study based on enrollment projections
• Review clinical research protocols to assess feasibility and serve as a resource, providing guidance, to study coordinators with planning and implementing strategies for successful participant recruitment.
• Managing all clinical trial workflow through UFIRST

Post Award Clinical Trial Management
• Maintain accurate accounts receivable and payable data
• Invoice sponsors for services rendered
• Reconcile all electronic study payments via the university’s clinical research system
• Prepare monthly reports outlining financial status of studies, enrollment target, etc. and present to PI and Assistant Director
• Facilitate timely reconciliation and close-out of terminated clinical trial accounts
• Maintain, oversee, reconcile, and correct errors in accounts. Process clinical research and core bills for payment
• Partner with Clinical Trial team on budgetary amendment implementation
• Manage clinical study financial closeout and residual balance transfers
• Oversee updates to documentation in response to IRB or Regulatory comments and queries, ensuring all regulatory documents are current and compliant, in conjunction with the clinical research coordinators
• Oversee the preparation and collation of all documentation required to support clinical trial applications, ensuring compliance with regulatory standards.
• Direct the development and review of briefing documents to facilitate effective meetings with regulatory bodies
• Coordinate the preparation and submission of annual reports, ensuring timely and accurate documentation.
• Implement and maintain a comprehensive document filing system for easy access and historical tracking of documentation across projects
• Supervise the renewal, re-registration, and submission of variations, amendments, and notifications, maintaining up-to-date regulatory status reports for all active projects

Team Management
• Function independently and proactively with strong critical thinking, analytical, and communication skills
• Support the Chief, Faculty, and Division Administrator in advancing the research missions of the Division of Infectious Diseases and Global Medicine.
• Collaborate closely with clinical research coordinators, the grants team, the Division Administrator, and the University’s clinical research hub to oversee the division’s clinical research activities.
• Provide training and support to divisional clinical research coordinators and serve as a clinical research coordinator for select clinical trials.
• Step in as a study coordinator as needed to support ongoing clinical trials and ensure continuity of research activities.
• Oversee the clinical research team staffing, working closely with clinical research coordinator 3’s to ensure the team is sufficiently and appropriately staffed

Other
•Assist the Division Administrator with ad hoc assignments to support basic science research faculty and laboratories.
• Prepare annual budget information to include in the division’s annual budget.
• Manage the division’s clinical trials operating account, including preparing annual projections for daily management and future staffing purposes.