Investigator-Initiated Trial; IIT) Senior Manager

Position: Investigator-Initiated Trial (IIT) Senior Manager

Job Summary

The Oncology Clinical Research Support Team (OCRST) provides comprehensive support for the Investigator-Initiated Trial (IIT) Program of the CU Cancer Center. The IIT Senior Manager is responsible for providing oversight of functional areas of the IIT Program including regulatory affairs, clinical project management, and clinical data monitoring. This position works closely with the OCRST Program Director, IIT Review Committee Chair, and IIT Incubator leadership team to define program objectives that align with the Cancer Center's overall strategic goals, lead meetings and activities related to new IIT development, and support ongoing management of the study portfolio.

This position assists the OCRST Program Director in forecasting program staffing needs and identifying, creating, and managing guidelines, policies, and best practices for areas of responsibility. The role oversees IIT operations, contributes to strategic planning and program growth, and supports personnel management across the IIT Program.
Key Responsibilities
• Oversee the IIT protocol opening process across all pipeline studies; serve as point of escalation and intervene as necessary to resolve obstacles.
• Hold regular meetings with IIT Program staff to review the IIT portfolio and status of studies in development, identify priorities or challenges, and intervene to ensure progress.
• Oversee IIT accrual monitoring activities, compile data for the IIT Review Committee on underperforming studies, and assist with follow-up activities as needed.
• Review IIT Site Selection and Feasibility Questionnaires, identify potential concerns or needed clarifications, and perform OCRST signoff.
• Review CAPA documents created by study teams in response to DSMC or other oversight entity requests prior to submission; suggest changes or clarifications as necessary to ensure responses are clear, thorough, and fully address identified issues.
• Ensure adherence to research standards set forth by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), University of Colorado Hospital, CU Anschutz, National Cancer Institute (NCI), and other pertinent regulatory agencies.
• Identify the need for policies, procedures, and educational materials related to the IIT Program and work within the management team to develop, implement, and maintain OCRST policies and procedures for conducting IITs.
• Collaborate with the OCRST Finance Program Manager as needed during all phases of the study life cycle.
• Coordinate or oversee coordination of IIT Incubator and IIT Review Committee meetings; collaborate with the OCRST Program Coordinator in setting agendas and ensure proper tracking and follow-up activities are completed.
20% - Strategic Planning / Leadership
• Participate in system implementation and development of standards for use, including Red Cap, Advarra EDC, eREG, project management software, and other systems.
• Provide regular reports to the OCRST Program Director and IIT leadership on program metrics, including study workloads and characteristics, opening timelines, and accruals.
• Develop internal relationships with CU Anschutz entities including CCTSI, CU Innovations, CRAO, clinical trial office/team leadership, and others that promote IIT development and operational success.
• Create team objectives to meet the Cancer Center's overall strategic goals with guidance from the OCRST Program Director and Deputy Associate Director of Clinical Research.
• Collaborate with the Data Safety Monitoring Committee, Protocol Review Monitoring Committee, other OCRST program areas, and clinical trial office(s) on initiatives as needed.
• Attend and participate in leadership and management courses for growth and skill development.
• Support IIT Program…