• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35

Position Summary

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. This position will report to Fort Lee, NJ 60% of the time and to the Columbia University Irving Medical Center in New York City 40% of the time.

Responsibilities

• 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%)

Minimum Qualifications

• 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 Qualifications

• 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.