Breast Oncology Clinical Research Coordinator – Trials & Data

MFS Investments; Boston (MA); On-site; USD 48,000 - 54,000; Full time

Job summary

Dana-Farber Cancer Institute in Boston seeks a Clinical Research Coordinator (CRC) to support the Breast Oncology Cohort Studies Program. You will manage data collection, regulatory compliance, and trial logistics under GCP guidelines, coordinating with multiple departments and sponsors.

Some travel may be required. You will maintain trial binders, assist with IRB submissions, and enter data into the Clinical Trial Management System, ONCORE, while ensuring timeliness of protocol assessments and

Qualifications

• Bachelor’s Degree or 1 year of Dana-Farber CRC experience required.
• 0-1 years of experience working in a medical or scientific research setting or comparable technology oriented business environment preferred.
• Excellent organization and communications skills required.

Responsibilities

• Oversee the clinical trials start-up process from protocol receipt through SRC and IRB submissions and site activation.
• Data reporting and management, collection of source documents, CRF development, AE reporting, filing and archiving study records, and data query resolution.
• Prepare and/or complete regulatory reports and IRB submissions; maintain study binders and enter data into the Clinical Trial Management System.
• Ensure timely collection, preparation and shipping of study samples per protocol and IATA/DOT regulations.
• Coordinate with Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, and Research Nursing.
• Prepare for internal and external auditing and study monitoring visits.
• Coordinate and manage trials across the life cycle and communicate with sponsors/regulatory authorities.
• Close-out activities including contributing to publications and regulatory communications.
• Interact with study participants per protocol; may collect tissue samples as required.

Skills

Organization skills

Communication skills

Interpersonal skills

Attention to detail

Time management

Discretion/confidentiality

Microsoft Office

Education

Bachelor’s Degree

CRC experience or equivalent

Tools

Microsoft Office

Job description

Dana-Farber Cancer Institute in Boston seeks a Clinical Research Coordinator (CRC) to support the Breast Oncology Cohort Studies Program. You will manage data collection, regulatory compliance, and trial logistics under GCP guidelines, coordinating with multiple departments and sponsors.

Some travel may be required. You will maintain trial binders, assist with IRB submissions, and enter data into the Clinical Trial Management System, ONCORE, while ensuring timeliness of protocol assessments and