Regulatory Coordinator (Cancer Therapeutic Innovation)

Location: Fully remote within Maine, Vermont, New Hampshire, Massachusetts, Connecticut, or Rhode Island, with occasional onsite work in Boston, Massachusetts

Salary: $55,530–$61,700 per year

Company

hirify.global conducts cancer research, provides patient care, advances treatment, and educates physician-researchers in partnership with Harvard Medical School-affiliated hospitals.

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, including IND/IDE applications, FDA annual reports, and serious adverse event reports.
• Maintain regulatory files, tracking databases, study documentation, and records of recruitment, enrollment, progress, and completion.
• Coordinate study start-up packets, submissions, monitoring visits, audits, safety reporting, and protocol amendments.
• Communicate with investigators, study teams, sponsors, regulatory agencies, research offices, and external institutions.
• Monitor regulatory requirements and present portfolio status at applicable research meetings.

Requirements

• Bachelor’s degree or one year of experience as a Dana-Farber Associate Regulatory Coordinator.
• Excellent written and oral communication, judgment, confidentiality, attention to detail, and follow-through.
• Strong organization, time management, prioritization, and independent work skills.
• Proficiency with computers, Microsoft applications, and databases.
• Experience with medical terminology.
• Ability to work remotely from an eligible New England state and attend the Boston campus occasionally.

Nice to have

• 0–1 years of experience in a medical, scientific research, or technology-oriented business environment.
• Basic understanding of clinical trial conduct.

Culture & Benefits

• Inclusive, diverse, and equitable research and care environment.
• Work supporting cancer research, clinical trials, and patient care.
• Collaboration with Harvard Medical School-affiliated hospitals and external research organizations.
• Remote work arrangement with occasional onsite presence in Boston.