The Herbert Irving Comprehensive Cancer Center (HICCC) at Columbia University Irving Medical Center seeks an experienced Assistant Director of Clinical Research Operations to serve as a key member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office.
CPDM is a core clinical research resource of HICCC, supporting investigators and research staff in the development and conduct of oncology clinical trials. The office provides administrative infrastructure and expertise to support investigator-initiated, industry-sponsored, and federally funded clinical research across Columbia University Irving Medical Center.
Position Summary
The Assistant Director of Clinical Research Operations provides leadership and operational oversight of the Clinical Research Coordination, Data, and Multicenter Cores within CPDM and supports the management of direct patient care activities for individuals enrolled in oncology clinical trials. Working closely with the Director of Clinical Research Operations, Medical Director, investigators, and institutional partners, this role ensures compliant, efficient, and high-quality clinical research operations. This position reports directly to the Director of Clinical Research Operations.
Responsibilities
Personnel & Operational Leadership
Supervise, mentor, and support CPDM staff to ensure efficient and compliant operations.
Conduct regular meetings with direct reports and complete performance evaluations.
Manage onboarding, training, time and attendance, and address performance issues as needed.
In collaboration with the Director, plan and manage staffing coverage across disease-based teams and the Multicenter Core.
Administrative Leadership
Serve as a member of the CPDM Executive and Leadership Committees.
Participate in cancer center–wide and institutional committees, as assigned.
Develop and implement policies, procedures, and standardized workflows.
Build and sustain relationships with internal and external stakeholders.
Support the strategic goals of CPDM, HICCC, and clinical research initiatives.
Communicate effectively and escalate operational issues appropriately.
Research Management
Oversee oncology clinical research operations to ensure compliance with institutional, federal, and state regulations (FDA, HHS, CMS, Joint Commission).
Support subject recruitment and retention initiatives.
Lead oversight of the Multicenter Trials Program, including sub-site management, monitoring, specimen collection, budgeting, invoicing, and fund tracking.
Develop and maintain standard operating procedures.
Financial Management
Prepare and review study budgets and multiyear financial projections.
Monitor budget performance, analyze variances, and develop mitigation strategies.
Ensure compliance with sponsor and funding agency financial requirements.
Oversee and optimize coordinator core charge-back models.
Develop financial dashboards and reports for leadership and investigators.
Serve as a liaison to institutional partners including CTO, SPA, IRBs, and the Irving Institute.
Minimum Qualifications
Bachelor’s degree or equivalent combination of education and experience.
Minimum of 4 years of related experience, including 5 years in oncology clinical research.
At least 2 years of management experience.
Strong interpersonal, organizational, and communication skills.
Proficiency with Microsoft Office; familiarity with Mac and PC platforms.
Preferred Qualifications
CCRP or CCRC certification (required within 6 months if not already obtained).
Please apply to:
https://opportunities.columbia.edu/jobs/assistant-director-clinical-research-operations-columbia-university-medical-center-new-york-united-states
If you have any questions reach out to Fran Brogan @
[email protected]