Project Coordinator- PRMC/DSMC

Job Type:

Officer of Administration Bargaining Unit:

Regular/Temporary:

Regular End Date if

Temporary:

Hours Per Week:

35

Standard Work Schedule:

Building:

Salary Range:

$80,000 - $85,000 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 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, amendments, and stipulations. Executes decisions regarding expedited approval and studies needing administrative approval. Tracks low accruing trials and is responsible for knowledge regarding trial accrual history and presenting these findings to the PRMC. Oversees all bi-monthly PRMC meetings, documentation of reviewer comments, distributes decision emails and monitor the progression of trials in need of revision. provides guidance on issues related to

DSMC/PRMC

regulations and actions. maintains electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and SOPs. Assists in the training of all new

PRMC/DSMC

members on review processes. interacts with Velos Data Specialists to provide and track all administrative and regulatory information on human subject's clinical research trials from activation to termination of the project Participates in the creation of standard operating policies and procedures. Create and analyze efficiency metrics for the PRMC and DSMC Chairs, as well as HICCC Executive Leadership. Provide applicable data and reports for HICCC grant renewals. Liaise with HICCC Shared Resources as needed to cultivate and maintain productive working relationships. Perform other related duties and responsibilities as assigned/requested. Minimum Qualifications Bachelor's degree or equivalent in education, training, and experience plus three years of related, clinical research experience. Preferred Qualifications Excellent interpersonal and organizational skills Ability to take initiative and work independently.

Computer Skills:

proficiency with MS Word programs and familiarity with Mac and PC platforms. Extensive knowledge of GCP, FDA, and DHHS policies. Experience with paper Case Report Forms (CRFs) and/or electronic research databases. Knowledge of medical terminology and procedures specifically related to oncology. Experience with Human Subjects clinical research QA/monitoring processes and audit procedures. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.