Remote Regulatory Coordinator, Breast Oncology

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

Job summary

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to manage regulatory submissions for a Breast Oncology project. The role coordinates protocol amendments, safety reports, and regulatory documentation across DF/HCC and external entities.

It requires collaboration with OHRS, ODQ, and trial sponsors. Responsibilities include start-up packet management, tracking submissions to SRC/IRB, and ensuring regulatory reporting compliance.

Qualifications

• Bachelor's degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator (preferred).
• 0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred.

Responsibilities

• Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for SRC/IRB review.
• Prepare regulatory documentation including IND/IDE applications and FDA reports.
• Maintain regulatory files for each study in compliance with sponsor requirements.
• Track regulatory information related to recruitment, enrollment, and progress.
• Coordinate study monitoring and auditing visits with stakeholders.

Skills

Regulatory coordination

Communication skills

Attention to detail

Microsoft Office

Medical terminology

Education

Bachelor's degree

Job description

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to manage regulatory submissions for a Breast Oncology project. The role coordinates protocol amendments, safety reports, and regulatory documentation across DF/HCC and external entities.

It requires collaboration with OHRS, ODQ, and trial sponsors. Responsibilities include start-up packet management, tracking submissions to SRC/IRB, and ensuring regulatory reporting compliance.