IRB Regulatory Specialist- Oncology

Job Type

Full Time

Salary

Details: Starting at 55k, negotiable and commensurate with experience

Published

08/08/2018

Address

1695 Eastchester Road
Bronx
New York
10461
United States

Description

Coordinate the regulatory components for clinical studies that are conducted through the Department of Medical Oncology, including, internal (investigator-initiated studies) and external/industrial protocols (pharmaceutical and biotechnology company studies).             


Responsibilities

  • Coordinates the full regulatory submission process of studies from PRMC to close-out
  • Complete the applications for review by the Protocol Review and Monitoring Committee and Data and Safety Monitoring Committee
  • Prepares and submits IRB applications to Montefiore IRB, external IRB's including new study submissions, amendments, annual review, and safety updates.
  • Reports on regulatory activity regarding pending and activated clinical trials to leadership team on a weekly basis
  • Ensures clinicians and key study personnel are up to date on all required certifications and training
  • Coordinates the regulatory preparation for internal and external audits, assist with preparation of audit response and process improvement as necessary
  • Communicates on a daily basis with the Montefiore IRB, external IRB's, PIs and/or research staff regarding regulatory management
  • Participates in protocol-specific meetings and conference calls as necessary
  • Educates and trains physicians and research staff about the research federal guidelines, policies, and requirements for participating in clinical trials
  • Monitors and maintains regulatory CTMS database to ensure appropriate regulatory procedures are tracked and monitored
  • Special projects for the department as needed

Professional Level

Professional

Minimum Education Required

4-year degree

How To Apply

aaraiza@montefiore.org

Email cover letter and resume to Anna L. Araiza at aaraiza@montefiore.org


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