Regulatory Coordinator - Massachusetts

Job Summary

Working remotely with occasional on-campus presence in Boston, the full-time Regulatory Coordinator - Massachusetts will manage regulatory submissions, maintain compliance records, and collaborate with clinical trial stakeholders to support Breast Oncology research projects.

Key responsibilities

• Prepares and submits protocol applications, amendments, and informed consent documents for review and approval
• Maintains regulatory files and tracking databases to ensure compliance with study sponsor requirements and regulatory agencies
• Facilitates communication among study team members, sponsors, and regulatory agencies regarding study status and compliance

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 business environment preferred
• Basic understanding of clinical trial conduct
• Proficiency in Microsoft applications and databases
• Experience with medical terminology