Breast Oncology Trials Coordinator – Data & Compliance

Dana-Farber Cancer Institute, Inc.; Boston (MA); On-site; USD 48,000 - 54,000; Full time

Job summary

Dana-Farber Cancer Institute, located in Boston, MA, is seeking a Clinical Research Coordinator to support the Breast Oncology Cohort Studies Program. The role focuses on data collection and management, ensuring timely trial assessments, and maintaining trial and regulatory binders in compliance with GCP and IRB requirements.

The CRC may screen patients for eligibility, obtain informed consent, and register study participants in ONCORE. Some travel may be required.

Qualifications

• Bachelor’s degree or 1 year Dana-Farber CRC experience required.
• 0-1 years of experience in a medical or scientific research setting preferred.
• Strong organizational and communication abilities.

Responsibilities

• Oversee start-up of trials from protocol receipt through IRB submissions and site activation.
• Data reporting and management, collection of source documents, adverse events reporting, and archiving.
• Prepare regulatory reports and IRB submissions; maintain study and regulatory binders; enter data in systems.
• Ensure collection, preparation, and shipment of trial samples per protocol and regulations.
• Collaborate with Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, and Research Nursing as needed.
• Coordinate internal and external audits and study monitoring visits; support sponsor communications.

Skills

Organization

Interpersonal skills

Attention to detail

Time management

Discretion

Education

Bachelor’s Degree

Tools

Microsoft Office

Job description

Dana-Farber Cancer Institute, located in Boston, MA, is seeking a Clinical Research Coordinator to support the Breast Oncology Cohort Studies Program. The role focuses on data collection and management, ensuring timely trial assessments, and maintaining trial and regulatory binders in compliance with GCP and IRB requirements.

The CRC may screen patients for eligibility, obtain informed consent, and register study participants in ONCORE. Some travel may be required.