The Herbert Irving Comprehensive Cancer Center (HICCC) at Columbia University Irving Medical Center seeks a Project Coordinator to support the Protocol Review and Monitoring Committee (PRMC) and Data Safety and Monitoring Committee (DSMC).
The PRMC and DSMC support the scientific review, prioritization, monitoring, and oversight of oncology clinical trials conducted by HICCC investigators. These committees help ensure clinical research is reviewed, monitored, and documented in accordance with Cancer Center Support Grant (CCSG) guidelines, FDA regulations, Columbia University Institutional Review Board policies, and institutional procedures.
Position Summary
The Project Coordinator for the PRMC and DSMC supports the daily operations of both committees and serves as a key point of contact for protocol information, committee communications, and administrative workflows. This role works closely with committee chairs, faculty reviewers, investigators, clinical research staff, and administrative teams to support compliant review, monitoring, and documentation of human subjects clinical research at HICCC.
This position reports to the Research Manager, Cancer Center Committees and is located in Fort Lee, NJ. Subject to business needs, flexible or hybrid work arrangements may be discussed during the interview process.
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Responsibilities
Committee Coordination
Coordinate bi-monthly PRMC and DSMC meetings.
Prepare and distribute agendas, meeting packets, and related materials.
Prepare accurate minutes documenting attendance, actions, votes, required changes, and resolution of stipulations.
Draft and distribute correspondence to investigators regarding committee decisions, approvals, stipulations, and required revisions.
Manage the PRMC inbox and correspondence with PIs and study teams.
Protocol Review and Monitoring
Collaborate with PRMC and DSMC Chairs to support reviewer assignments and review workflows.
Collect, reconcile, track, and distribute required reports, including serious adverse events and safety reports.
Support administrative and expedited approval processes, as appropriate.
Track low-accruing trials, maintain knowledge of accrual history, and present findings to the PRMC.
Document reviewer comments, distribute decision notices, and monitor trials requiring revision.
Regulatory and Administrative Support
Provide guidance to investigators and research staff on PRMC and DSMC processes and committee actions.
Maintain electronic files and regulatory documents in accordance with federal regulations, institutional policies, and SOPs.
Work with Velos Data Specialists to track administrative and regulatory information from study activation through termination.
Assist with onboarding and training new PRMC and DSMC members.
Support development and revision of standard operating policies and procedures.
Create and analyze efficiency metrics for PRMC and DSMC Chairs and HICCC leadership.
Prepare data and reports for HICCC grant renewals.
Liaise with HICCC Shared Resources and other stakeholders.
Perform other related duties as assigned.
Minimum Qualifications
Bachelor’s degree or equivalent combination of education, training, and experience.
Minimum of 3 years of related clinical research experience.
Excellent interpersonal, organizational, and written communication skills.
Ability to take initiative, prioritize tasks, and work independently.
Proficiency with Microsoft Word and familiarity with Mac and PC platforms.
Preferred Qualifications
Knowledge of GCP, FDA, DHHS, and human subjects research requirements.
Experience with case report forms and/or electronic research databases.
Knowledge of oncology medical terminology and clinical procedures.
Experience with clinical research quality assurance, monitoring, or audit processes.