REGULATORY MANAGEMENT
• Oversee the preparation and collation of all documentation required to support clinical trial applications, ensuring compliance with regulatory standards.
• Lead the preparation of IRB applications and maintain regulatory and IRB approvals throughout the project lifecycle.
• 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.
• Manage updates to documentation in response to IRB or Regulatory comments and queries, ensuring all regulatory documents are current and compliant.
• 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

CLINICAL RESEARCH MANAGEMENT
• 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 Office of Clinical Research to oversee the division’s clinical research activities.
• Manage pre- and post-award financials, including invoicing sponsors for services and reconciling electronic study payments via the university’s clinical research system.
• Assist the Division Administrator with ad hoc assignments to support basic science research faculty and laboratories.
• 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.
• Provide training and support to divisional clinical research coordinators and serve as a clinical research coordinator for select clinical trials.

ADDITIONAL RESPONSIBILITIES
• Step in as a study coordinator as needed to support ongoing clinical trials and ensure continuity of research activities.
• 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.

Familiarity with regulatory documentation and clinical trials.
Strong communication skills, good organization, detail oriented, familiarity with medical environment.