Columbia University Regulatory Coordinator in New York, New York

Job TitleRegulatory Coordinator

Job Code Title

Job Requisition Number 096274

Department 7571- HIC HICCC

Location Medical Center

Job Type Officer Full-Time Regular

Bargaining Unit

If temporary, indicate duration

Hours Per Week

Job Family General Administration

Salary Grade Officer 103

Salary Range

Advertised Summary Job Description 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 Associate Director of Regulatory Affairs 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 and 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.

Multiple positions of this title will be filled.

Minimum Qualifications for Grade

Applicant MUST meet these minimum qualifications to be considered an applicant Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.

Additional Position-Specific Minimum Qualifications

Applicant MUST meet these minimum qualifications to be considered an applicant - Excellent interpersonal and organizational skills.

  • Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).

Special Instructions

Preferred Qualifications Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.

Essential Functions Responsibilities include, but are not limited to:

Coordinates all aspects of protocol submission for research projects. (25%)

  • 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. (45%)

  • 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. (15%)

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

Serves as an integral part of disease specific research teams. (10%)

  • 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. (5%)

Additional Essential Functions (Limit to 3950 characters.)

Special Indications

This position works with:

HIPAA Compliance training required Yes

Participation in Medical Surveillance required No

What type of posting? Is this a waiver request? Standard Posting

Requisition Open Date 08-20-2018

Requisition Close Date Open Until Filled

Quick Link

EEO Statement Columbia University is an Equal Opportunity/Affirmative Action employer --Race/Gender/Disability/Veteran.

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

This organization is a federal contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA). The final rules now require contractors and subcontractors to invite applicants to self-identify as protected veterans or individuals with disabilities.

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