Assistant Director, Clinical Research Operations

Position Summary

The Assistant Director of Clinical Research Operations is an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). The CPDM is a clinical resource of the HICCC that assists investigators and academic/research staff in developing oncology clinical trials and provides administrative resources and infrastructure to build and sustain investigator initiated, industry, and federally sponsored clinical research at the HICCC of P&S.

Responsibilities

• Maintains efficient level of operations through monitoring, directing, and supervising staff.
• Serves as a role model and resource to other members of the office.
• Meets regularly with direct reports and performs and reviews Performance appraisals.
• Provides counseling or performance improvement plans as needed.
• Evaluates, plans, and manages appropriate coverage of disease teams and multicenter core.
• Manages tracking of time and attendance and evaluates employee’s orientation and ongoing training.
• Participates in CPDM leadership and other cancer center committees as assigned.
• Develops and promotes a structure that increases efficiency and streamlines processes.
• Assigns the Clinical coordination, Regulatory and Multicenter core to appropriate committees per their job description.
• Creates and implements policies and procedures to ensure operational standardization.
• Builds and sustains relationships with internal and external stakeholders.
• Supports the strategic plan for the organization and for clinical research.
• Communicates effectively (written & oral) across the organization and escalates unresolved issues to appropriate levels of management.
• Identifies and initiates improvements, tools, processes, and forms to enhance the efficiency and quality of work.
• Supports efforts to recruit and maintain adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements.
• Works cohesively with the Medical Director, Investigators, and CPDM staff to assure compliant conduct of research protocols.
• Develops and implements policies and procedures for all oncology clinical research functions designed to ensure that clinical trials at HICCC are carried out in compliance with applicable institutional, federal, and state regulations.
• Develops and oversees programs for subject recruitment and retention.
• Oversees multicenter trials program including all sub-site management, auditing/monitoring, specimen collection, budget negotiations, invoicing/payments, and research fund accounting.
• Develops and implements standard operating procedures.
• Prepares and reviews detailed budgets for grant and contract applications, ensuring accuracy, competitiveness, and alignment with sponsor expectations.
• Maintains and reports on approved budgets, develops action plans to address gaps, and presents multiple financial scenarios to achieve departmental goals.
• Ensures compliance with all funding agencies and identifies, analyzes, and corrects any discrepancies.
• Monitors, reports, and explains variances to approved budget; addresses variances and presents alternatives for achieving goals.
• Manages and optimizes service center charge-back models for the Coordinator Core, working closely with the Finance Team and the Director of Clinical Research Operations.
• Serves as a liaison with internal partners in research such as the Clinical Trials Office (CTO), Sponsored Projects Administration (SPA), the Institutional Review Boards (IRBs), and the Irving Institute for Clinical and Translational Science.
• Identifies opportunities to streamline financial processes through technology integration (e.g., dashboards, automation tools, financial trackers) and implements best practices to reduce delays in invoicing, milestone payments, and fund reconciliation.
• Develops financial dashboards and reports for leadership, disease-based teams, and investigators, providing transparency into trial performance, fund balances, and resource utilization.

Minimum Qualifications

• Requires a Bachelor’s degree or equivalent in education plus 5 years of related experience.
• Master's degree preferred.
• Minimum of 2-years Management experience.
• 5 years of Oncology Research experience.
• Excellent interpersonal and organizational skills.
• Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms.
• CCCR/CCRC certification preferred but should be completed within 6 months of promotion.