Regulatory Coordinator Position Available In Bergen, New Jersey

Regulatory Coordinator
550336
Parker Plaza, Fort Lee, NJ
Herbert Irving Comprehensive Cancer Center
Full Time
Opening on: Jun 17 2025
Grade 103

Job Type:

Officer of Administration

Bargaining Unit:

Regular/Temporary:

Regular
End Date if

Temporary:

Hours Per Week:

35

Standard Work Schedule:

Building:

Salary Range:

$64,350 – $67,000
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
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 subject 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 the 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
Performs other miscellaneous tasks as needed.
Coordinator performs other related duties and participates in special projects as assigned.
Minimum Qualifications
Bachelor’s degree or equivalent in education and experience.
Preferred Qualifications
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.