Assistant Director, Clinical Research Operations

Grade 106 Job Type: Officer of Administration Bargaining Unit: Regular/Temporary: Regular End Date if Temporary: Hours Per Week: 35 Standard Work Schedule: Building: Salary Range: $130,000 - $140,000 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. 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. The Assistant Director of Clinical Research Operations is an experienced professional who provides leadership and oversight of the daily activities of the CPDM Clinical Research Coordination, Data and Multicenter cores as well as assisting in the management of the direct care of patients enrolled in clinical trials within the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center. Along with other members of the leadership team, the Assistant Director will assist the development of standards and guidance in order to maintain compliant and efficient clinical trials operations. This position reports directly to the Director of Clinical Research Operations. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process. Responsibilities Responsibilities include, but are not limited to: Personnel Management Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations. Serve as a role model and resource to other members of the office. Meet regularly with direct reports. Perform and review Performance appraisals. Provides counseling or performance improvement plans as needed. In collaboration with the Director of Clinical Research Operations evaluate, plan and manage appropriate coverage of disease teams and multicenter core. Manages tracking of time and attendance. Manages and evaluates employee’s orientation and ongoing training. Administrative Participate in CPDM leadership and other cancer center committees as assigned. Member of the CPDM executive and leadership committee. Participate in cancer center wide and other committees. Develop and promote a structure that will increase efficiency and streamline processes. Assigns the Clinical coordination, Regulatory and Multicenter core to appropriate committees per their job description. Create and implement policies and procedures to ensure operational standardization. Build and sustain relationships with internal and external stakeholders. Support the strategic plan for the organization and for clinical research. Effectively communicate (written & oral) across the organization. Communicate and elevate unresolved issues at the appropriate time to the appropriate level of management. Identify and initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work. Support efforts to recruit and maintain adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements. Work cohesively with the Medical Director, Investigators and CPDM staff to assure compliant conduct of research protocols. Research Management Develop and implement 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. These include those promulgated by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services, and the Joint Commission. Develop and oversee programs for subject recruitment and retention. Oversee multicenter trials program including all sub-site management, auditing/monitoring, specimen collection, budget negotiations invoicing/payments and research fund accounting. Develop and implement standard operating procedures. Finance Management Prepares and reviews detailed budgets for grant and contract applications, ensuring accuracy, competitiveness, and alignment with sponsor expectations. Builds multiyear financial models that project revenue, accrual targets, and staffing needs. Monitors, reports, and explains variances to approved budgets. Develops action plans and presents multiple financial scenarios to address gaps while still achieving departmental goals. Utilizes forecasting tools to anticipate shortfalls and opportunities. Develop and implements strategies to ensure the financial health and sustainability of both individual studies and the department as a whole. Aligns financial planning with institutional goals, long-term growth projections, and portfolio diversification strategies. Oversee compliance with all funding agencies to assure that all required information is maintained and reported on a regular basis while identifying, analyzing and correcting any discrepancies. Monitors, report and explain variances to approved budget; address variances and present alternatives for achieving the 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. Develops metrics to evaluate cost-effectiveness and sustainability of these models. Serve 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). 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. Ensures decision-makers have timely, actionable financial insights. Perform other related duties and responsibilities as assigned/requested. Minimum Qualifications Requires a Bachelor’s degree or equivalent in education plus 5 years of related experience. Preferred Qualifications 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. CCRP/CCRC certification preferred but should be completed within 6 months of promotion. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents. #J-18808-Ljbffr Columbia University Irving Medical Center