Hybrid Regulatory Coordinator for Clinical Trials

Dana-Farber Cancer Institute; Brookline (MA); Hybrid; USD 61,110 - 67,900; Full time

Job summary

Dana-Farber Cancer Institute in Brookline, MA seeks a Regulatory Coordinator II to manage regulatory requirements for clinical research projects under the Clinical Trials Office. You will prepare submissions, maintain study records, and ensure compliance with DFCI/DF/HCC policies and federal regulations.

Hybrid work with 2–3 days remote/onsite; collaboration with OHRS, ODQ, sponsors, and external institutions.

Qualifications

• Must have strong written and oral communication skills.
• Ability to work independently with good time management and prioritization.
• Proficient in computer use, Microsoft applications, and data systems.

Responsibilities

• Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for IRB review.
• Maintain regulatory tracking databases related to recruitment, enrollment, and study progress.
• Organize regulatory files for each study in compliance with sponsor requirements.
• Submit regulatory documents (IND/IDE, FDA annual reports, SAE reports) to regulatory agencies as needed.
• Coordinate start-up activities and monitor progress to meet benchmarks.
• Communicate with study teams, sponsors, and regulatory bodies to ensure timely information sharing.

Skills

Communication

Organization

Microsoft Office

Medical terminology

Education

Bachelor's degree

Job description

Dana-Farber Cancer Institute in Brookline, MA seeks a Regulatory Coordinator II to manage regulatory requirements for clinical research projects under the Clinical Trials Office. You will prepare submissions, maintain study records, and ensure compliance with DFCI/DF/HCC policies and federal regulations.

Hybrid work with 2–3 days remote/onsite; collaboration with OHRS, ODQ, sponsors, and external institutions.