Remote Regulatory Coordinator – Clinical Trials

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

Job summary

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to support regulatory operations across Lymphoma clinical trials. This role collaborates with DF/HCC entities, OHRS, ODQ, and external partners to ensure compliance with ICH/GCP and FDA guidelines.

The position is fully remote with occasional on-campus time in Boston, MA, and may be performed remotely from New England states. A bachelor’s degree and regulatory experience are required.

Qualifications

• Must possess strong regulatory knowledge of FDA/IRB processes.
• Experience maintaining regulatory files and tracking databases.
• Excellent written and verbal communication with meticulous attention to detail.

Responsibilities

• Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for SRC/IRB review.
• Prepare regulatory documents including IND/IDE, FDA reports, and SAE reports for agencies.
• Maintain regulatory files and tracking systems for assigned studies.
• Enter and manage data in the clinical trial management system in alignment with visits and activities.
• Coordinate with stakeholders to ensure timely regulatory submissions and audits.

Skills

Regulatory knowledge

Documentation management

Communication skills

Time management

Microsoft Office

Clinical trials terminology

Education

Bachelor's degree

Tools

Regulatory databases

IRB systems

Job description

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to support regulatory operations across Lymphoma clinical trials. This role collaborates with DF/HCC entities, OHRS, ODQ, and external partners to ensure compliance with ICH/GCP and FDA guidelines.

The position is fully remote with occasional on-campus time in Boston, MA, and may be performed remotely from New England states. A bachelor’s degree and regulatory experience are required.