* Requisition no: 503491 * Work type: Full Time * Location: Medical Center * School/Department: Herbert Irving Comprehensive Cancer Center * Grade: Grade 103 * Categories: Administrative Support, Compliance
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
* 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%)
* Bachelor's Degree or equivalent in education and experience, plus 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.
Applications open: Sep 26 2019 Eastern Daylight Time Applications close:
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.