Regulatory Coordinator - Breast Oncology

Responsibilities

• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
• Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc
• Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors
• Track and manage assigned new protocol start-up packet; initiate, facilitate, and monitor study start-up progress to ensure established benchmarks are met
• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed
• Create and maintain tracking for all subsequent submissions to the SRC/IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exception, or other event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA, IRB etc
• Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable
• Serve as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable
• Maintain working knowledge of current regulations, regulatory guidance and or local policies
• Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
• Present regulatory status for disease group portfolio at applicable research meetings

Preferred

• 0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred
• a basic understanding of clinical trial conduct

Benefits

• Fully remote work with occasional time on-campus in Boston; remote work is limited to a New England state (ME, VT, NH, MA, CT, RI).
• Glassdoor
• 3.9
• Cancer treatment and research institute for children and adults.
• Boston, Massachusetts, USA
• http://www.dana-farber.org
• Late Stage
• Total Funding
• $138.08M
• Key Investors
• Yawkey Foundation
• Elaine and Eduardo Saverin Foundation
• The DeGregorio Family Foundation
• 2026-06-09
• Grant· $50M
• 2025-11-24
• Grant· $20M
• 2025-05-06
• Grant· $1M
• Leadership Team
• Benjamin Ebert
• President and CEO
• Prafulla Gokhale
• Director, Lurie Family Imaging Center
• Recent News
• Boston Globe
• Dana-Farber, Beth Israel begin construction of new $1.68 billion cancer hospital
• 2026-10-19
• PR Newswire
• Alpheus Medical Opens Enrollment in New Clinical Trial for Butterfly Glioblastoma

Qualifications

• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required
• Must be proficient in the use of computers, Microsoft applications and databases
• Requires experience with medical terminology
• The position requires a 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 is preferred
• A basic understanding of clinical trial conduct
• The position requires a bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator.

Required skills

• Microsoft Applications

Preferred skills

• a basic understanding of clinical trial conduct

Experience

• Entry level