Regulatory Coordinator - Sarcoma Clinical Trials

Location: Fully remote, never on campus; work is limited to Maine, Vermont, New Hampshire, Massachusetts, Connecticut, or Rhode Island.

Salary: $55,530–$61,700 per year

Company

hirify.global conducts cancer research, provides patient care, educates physician-researchers, and collaborates with Harvard Medical School-affiliated hospitals and other research organizations.

What you will do

• Prepare and submit protocol applications, amendments, continuing reviews, informed consent documents, and other materials for SRC and IRB review.
• Prepare regulatory submissions and reports for agencies including the FDA and Office of Biotechnology Activities.
• Maintain organized regulatory files and tracking databases covering recruitment, enrollment, study progress, submissions, safety reports, and protocol events.
• Coordinate study start-up packets, monitor progress against benchmarks, and facilitate communication among study teams, sponsors, investigators, and regulatory offices.
• Assist with monitoring and auditing visits and present regulatory status for the sarcoma research portfolio.
• Maintain knowledge of regulations and support regulatory training and implementation of updated guidance and policies.

Requirements

• Bachelor’s degree or one year of experience as a Dana-Farber Associate Regulatory Coordinator.
• Basic understanding of clinical trial conduct and experience or exposure to a medical, scientific research, or technology-oriented environment.
• Experience with medical terminology.
• Proficiency with computers, Microsoft applications, and databases.
• Strong written and oral communication, organization, time management, judgment, attention to detail, and ability to work independently.
• Must work remotely from an eligible New England state; the position has no patient contact or supervisory responsibilities.

Culture & Benefits

• Fully remote work arrangement with no campus attendance.
• Inclusive, diverse, and equitable environment focused on compassionate patient care and public health.
• Work alongside clinical research teams, academic institutions, pharmaceutical companies, federal agencies, and external research organizations.
• Participation in research that advances cancer treatment and reduces the burden of cancer.