Hybrid Regulatory Coordinator – Clinical Trials Office

MFS Investments; Brookline (MA); On-site; USD 61,000 - 68,000; Full time

Job summary

Dana-Farber Cancer Institute seeks a Regulatory Coordinator II to manage regulatory aspects of clinical trials under the Clinical Research Administration. The role coordinates protocol submissions, prepares regulatory documents, and maintains records to ensure compliance with DF/HCC policies, FDA, and ICH/GCP guidelines.

The position operates in a hybrid model (Brookline area) with two to three remote/onsite days; candidate may work remote days from New England states.

Qualifications

• Bachelor's degree or 2 years of experience as a Dana-Farber Regulatory Coordinator, plus 1-3 years of direct regulatory experience.
• Intermediate to advanced knowledge of FDA and ICH/GCP guidelines.
• Prior experience with clinical trials or research coordination.

Responsibilities

• Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for SRC/IRB review and approval.
• Assist in coordinating study monitoring and auditing visits with study teams, ODQ, industry sponsors, and auditors.
• Maintain regulatory tracking databases for recruitment, enrollment, and progress.
• Prepare and organize regulatory files in compliance with sponsor and DF/HCC requirements.
• Submit regulatory documentation (IND/IDE, FDA reports) to appropriate agencies including FDA and OBA.
• Track startup progress and ensure milestones are met.
• Communicate with stakeholders to provide updates throughout start-up and study progression.
• Maintain systematic documentation/tracking and regulatory reporting to sponsors, FDA, IRB, etc.

Skills

Communication

Organization/time management

Computer literacy

Medical terminology

Education

Bachelor's degree or equivalent experience

Job description

Dana-Farber Cancer Institute seeks a Regulatory Coordinator II to manage regulatory aspects of clinical trials under the Clinical Research Administration. The role coordinates protocol submissions, prepares regulatory documents, and maintains records to ensure compliance with DF/HCC policies, FDA, and ICH/GCP guidelines.

The position operates in a hybrid model (Brookline area) with two to three remote/onsite days; candidate may work remote days from New England states.