Senior Regulatory Consultant

Overview

Senior Regulatory Compliance Coordinator role in the Cancer Clinical Trials Office.

• Manage cancer clinical trials through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure.
• Develop new clinical trials and act as the main contact during the protocol development phase.
• Correspond with reviewing committees and personnel; assist in budget development by identifying research non-billables.
• Coordinate start-up meetings for new protocols.
• Mentor junior staff by providing oversight and training to multiple study teams who develop and submit documentation for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
• Serve as a resource for Investigators and Research Teams.

• Education:
  
  Bachelor’s Degree Required (preferred Life Science or Health Policy).
  
  Preferred Education:
  
  Master’s Degree (preferred Life Science or Health Policy).
• Certifications:
  
  SOCRA or ACRP certification preferred.
• Prior
  
  Experience:
  
  Minimum 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance.

• City/State: Bronx, New York
• Grant Funded: Yes
• Department: Cancer Clinical Trials Office
• Work Shift: Day
• Work Days: MON-FRI
• Scheduled
  
  Hours:
  
  9 AM-5:30 PM
• Scheduled Daily
  
  Hours:
  
  7.5 HOURS
• Pay Range: $72,000.00-$90,000.00

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.