Remote Regulatory Coordinator, Breast Oncology Trials

Dana-Farber Cancer Institute; Boston (MA); Remote; USD 56,000 - 62,000; Full time

Job summary

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to manage regulatory submissions, maintain trial documents, and ensure compliance with DF/HCC policies, FDA, and ICH/GCP guidelines. The role collaborates with investigators, sponsors, OHRS, ODQ, and trial teams.

Work location is fully remote with occasional on-campus time in Boston; remote work allowed from New England states. The team supports breast oncology studies and collaborates across DF/HCC institutions.

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, with basic understanding of clinical trial conduct.
• Excellent written and oral communication, confidentiality, attention to detail and strong organization.
• Proficient in computers and databases; experience with medical terminology.

Responsibilities

• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent for SRC/IRB review.
• Prepares regulatory documentation including IND/IDE, FDA reports, and SAEs to FDA and other agencies.
• Maintains regulatory files per sponsor requirements for various study types.
• Maintains regulatory tracking databases for recruitment, enrollment, and study progress.
• Assists in coordinating study monitoring visits with investigators, sponsors, and auditors.
• Tracks start-up packets and monitors progress to meet benchmarks.
• Communicates with stakeholders to ensure start-up activities are completed.
• Creates and maintains tracking for SRC/IRB submissions, safety reporting, deviations, and events.
• Maintains regular communication with study teams, sponsors, and regulatory offices for information flow.
• Serves as facilitator for study status, safety issues, and regulatory training; documents accordingly.
• Keeps up-to-date with current regulations and local policies; supports regulatory training.

Skills

Regulatory knowledge

Documentation management

Communication skills

Microsoft Office

Medical terminology

Education

Bachelor's degree

1 year Dana-Farber Associate Regulatory Coordinator experience

Tools

Regulatory databases

Job description

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to manage regulatory submissions, maintain trial documents, and ensure compliance with DF/HCC policies, FDA, and ICH/GCP guidelines. The role collaborates with investigators, sponsors, OHRS, ODQ, and trial teams.

Work location is fully remote with occasional on-campus time in Boston; remote work allowed from New England states. The team supports breast oncology studies and collaborates across DF/HCC institutions.