Job Description

  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.
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