Regulatory Coordinator - Massachusetts

Job Summary

To support Breast Oncology clinical research projects, the full-time Regulatory Coordinator - Massachusetts will manage protocol submissions, prepare regulatory documents, and maintain compliance records while working remotely with occasional on-campus meetings in Boston.

Key responsibilities

• Prepares and submits protocol applications, amendments, and informed consent documents for review and approval
• Maintains and organizes regulatory files for assigned studies in compliance with sponsor requirements
• Tracks and manages new protocol start-up packets, ensuring established benchmarks are met

Required qualifications

• Bachelor's degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator
• 0-1 years of experience in a medical, scientific research, or technology-oriented environment preferred
• Basic understanding of clinical trial conduct
• Proficiency in Microsoft applications and databases
• Experience with medical terminology