Regulatory Coordinator

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 position will coordinate regulatory activities of human subjects / clinical research protocols being conducted through the Clinical Protocol & Data Management (CPDM) Office within the Herbert Irving Comprehensive Cancer Center (HICCC).

Under the direction of the Assistant Director of Clinical Research Operations and the supervision of the Regulatory Manager, the Regulatory Coordinator will assist in the start-up and management of clinical studies in the CPDM Office. The Regulatory Coordinator will assist with IRB / FDA submissions and preparing / maintaining protocol-specific regulatory documents for the initiation, implementation, ongoing monitoring, and formal closure of assigned clinical trials. Will serve as a primary regulatory contact for studies (for both internal and external stakeholders); ensuring that regulatory compliance is met and that regulatory files are audit ready. This position is primarily based out of 400 Kelby Street, Fort Lee, NJ.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

Responsibilities include, but are not limited to :

Coordinates all aspects of protocol submission for research projects.

• Prepares and submits all necessary documents to the Institutional Review Board (IRB) and Protocol Review Monitoring Committee (PRMC), and ancillary committees.

Ensures regulatory approvals for all required components of human subjects research / clinical trials are obtained and maintained accordingly.

• Annual IRB renewal submissions and ancillary review committee annual reports.
• FDA annual reports (as needed).
• Timely submission of all required documents.
• Official reporting of Unanticipated Problems to the IRB of record (as applicable).

Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal / external auditors.

• Assists in preparations for routine monitoring and audit visits for assigned clinical trials.

Serves as an integral part of disease specific research teams.

• Attend and present at recurring research team meetings.
• Maintains and disseminates accurate listings of active and potential studies to participating investigators.
• Serves as the resource for current regulatory information / statuses for assigned protocols.
• Perform other related duties and responsibilities as assigned / requested.

Minimum Qualifications

• Bachelor's Degree or equivalent in education and experience.

Preferred Qualifications

• Two years of related experience.
• Excellent interpersonal and organizational skills.
• Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
• Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and / or SOCRA.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.