Location: Fort Lee, NJ
Cap-Exempt H-1B Position — No lottery required
The Project Coordinator for the PRMC and DSMC is responsible for assisting in the operational oversight of the Protocol Review and Monitoring Committee (PRMC) and the Data Safety and Monitoring Committee (DSMC) in accordance with guidelines set forth by CCSG, the Food and Drug Administration, as well as the Columbia University Institutional Review Board policies and procedures mandated for compliance in clinical trials involving human subject clinical research. The candidate interacts with staff members to facilitate compliance in the administrative and regulatory conduct of human subjects’ clinical trials conducted by Principal Investigators in the Herbert Irving Comprehensive Cancer Center (HICCC). Incumbent serves as conduit of protocol information to departmental faculty, clinical, and research staff. This position reports directly to the Research Manager Cancer Center Committees. This position is located at 400 Kelby St. Fort Lee, NJ. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process. Responsibilities - coordinates bi-monthly Protocol Review and Monitoring Committee (PRMC) meetings and Data and Safety Monitoring Committee (DSMC) meetings - creates and disseminates meeting agendas including meeting packets. - prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in research, and a written summary of and their resolution. - prepares written correspondence to investigators of applicable DSMC/PRMC actions and decisions. - Manages collection and distribution of reports. - Reviews, reconciles and track all safety reports including Serious Adverse Events - Collaborates with the Chair of the DSMC to oversee the assignment of new trial. - Collaborates with the Chair of the PRMC to assign reviewers to studies. - Manages the PRMC inbox and all correspondences with PIs regarding protocol approvals,