Regulatory Coordinator - Oncology

Job Summary

To support Head & Neck Oncology clinical research, the full-time Regulatory Coordinator - Oncology will manage protocol submissions, prepare regulatory documents, and ensure compliance with applicable regulations while working remotely with occasional on-campus requirements in Boston, MA.

Key responsibilities

• Prepares and submits protocol applications, amendments, and informed consent documents for review and approval
• Maintains and organizes regulatory files for assigned studies, ensuring compliance with sponsor requirements
• Communicates and collaborates with clinical trial stakeholders to track and manage study start-up progress and regulatory submissions

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
• Familiarity with medical terminology