Position Summary Responsible for the executive oversight, planning and direction of all cancer clinical research operations at Weill Cornell Medicine and NewYork-Presbyterian Hospital. This includes oversight of the processes related to study activation and conduct for all cancer clinical trials and accountability for continual improvement of the quality and efficiency of the Cancer Center Clinical Trials Office (CCTO). This role works closely with Meyer Cancer Center (MCC) leadership, Principal Investigators and study teams to ensure the highest level of regulatory compliance, decrease timelines for study activation and continually improve and streamline clinical research processes and workflows. In close collaboration with the Associate Director for Clinical Research and the CCTO Medical Director, this role significantly contributes to the MCC's success in achieving clinical research goals and obtaining/maintaining NCI designation.
Serves as the Institutional authority on best practices for cancer clinical trials management and regulations governing the responsible conduct of clinical research.
Serves as key liaison with Meyer Cancer Center (MCC) and institutional leadership to develop and maintain a clinical research infrastructure compatible with NCI expectations; assists with defining and achieving both short- and long-term goals.
Leads/oversees clinical trials staff. Recruits, supervises and mentors mid/senior-level managers to oversee portfolio of clinical trials. Provides guidance on ways to optimize staff performance and improve workflows impacting clinical trials operations.
Oversees maintenance of cancer-specific protocols, related data, and reporting in OnCore. Facilitates submission of required study data to CTRP and clinicaltrials.gov.
Develops, revises and implements policies/processes related to annual clinical trials budgeting and projections for CCTO. Presents quarterly P&L reports to leadership, monitoring year-to-date subject enrollments and budget to actual revenue and expenses.
Oversees the budgeting process for study-specific clinical trials and assists with the standardization of rates and justifications to help level-set negotiations with Sponsors.
Develops and maintains Standard Operating Procedures (SOP) for study activation and conduct. Implements appropriate education and training to ensure compliance with SOPs within the CCTO.
Monitors progress of SOP committee to ensure all policies are updated and maintained in accordance with internal timelines and in line with federal regulations, good clinical practice and institutional policies.
Collaboratively leads Protocol Review and Monitoring System (PRMS) oversight committee. Facilitates CCTO support required for Disease Management Teams (DMT) and Feasibility Review Committee (FRC).
Collaborates with Human Research Protection and Compliance for support and coordination of the Data Safety Monitoring Committee (DSMC).
Participates as a member of the Clinical Research Leadership Committee (CRLC). Develops and provides metrics driven reports to monitor submission and approval timelines, study portfolio, enrollment targets and updates on activities within the CCTO.
Serves as CCTO representative on institution-led committees to improve and streamline the workflows for study activation and/or conduct. Serve as clinical trial operations expert, as needed, during implementation of new research administrative systems.
Provides administrative oversight for MCC held electronic systems and initiatives.
Directs efforts in preparing for NCTN, NCI, Sponsor and FDA audits. Provides guidance to PI and study teams during audit preparation process to manage deviations and discrepancies. Reviews corrective action plans and ensures appropriate implementation.
Collaborates with/provides guidance to Joint Clinical Trials Office (JCTO) Quality Assurance Unit (QAU) for auditing, monitoring and educational requirements as outlined in NCI CCSG guidelines, specifically Clinical Protocol and Data Management (CPDM).
Facilitates audit and monitoring activities to ensure preparedness of investigators and study teams. Reviews monitoring reports and provides updates to CRLC on outcomes and corrective action.
Participates in the development of initial and ongoing educational programs for investigators and study teams in the MCC. Engages QAU services when corrective action retraining is required.
Collaboratively facilitates communications with investigators and study teams; prioritizes and troubleshoots issues with contracts and financial activities. Participates in process improvement projects and provides operations perspective and impact.
Bachelor's degree in healthcare management or related field. Master's Degree (MS, MPH, MBA, etc.) is highly desired.
Minimum of 8 years of experience in clinical trial operations, with at least 5 years in a managerial or leadership role.
Certification in clinical research (CCRP, ACRP) desired.
Experience with NCI designated cancer center requirements preferred.
Experience with OnCore preferred.
Knowledge, Skills and Abilities
In depth knowledge about all aspects of clinical research administration and operations, particularly best practices for study activation and conduct.
Ability to lead and direct large, diverse work groups engaged in widely divergent areas.
Strong attention to detail and ability to manage multiple complex assignments simultaneously.
Strong understanding of the pre/post award processes of private and public research funding.
Ability to foster positive relationships with Principal Investigators and Clinical, Scientific and Administrative leadership.
Ability to work with complex data and generate meaningful reports.
Weill Cornell Medicine is a comprehensive academic medical center that's committed to excellence in patient care, scientific discovery, and the education of future physicians in New York City and around the world. Our doctors and scientists-faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization-are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at New York-Presbyterian Hospital/Weill Cornell Medical Center, New York-Presbyterian/Lower Manhattan Hospital, and New York-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.