Senior Regulatory Lead – Remote

Fred Hutchinson Cancer Research Center; Seattle (WA); Remote; USD 80,000 - 121,000; Full time

Job summary

Fred Hutchinson Cancer Center is seeking a Senior Regulatory Coordinator to provide advanced regulatory expertise for activation, maintenance, and compliance oversight of clinical studies. This role manages complex multisite trials and partners with investigators, IRBs, and sponsors to ensure timely, compliant study conduct.

The position supports regulatory staff, mentors coordinators, and helps with onboarding and training materials.

Qualifications

• Bachelor’s degree in biological, social or physical science.
• Two years of regulatory or clinical trials and/or prevention study management experience.
• Experience with protocol design and review.

Responsibilities

• Independently manage regulatory startup, amendments, continuing review, and closeout for moderate to highly complex clinical trials, including multisite, cooperative group, and investigator‑initiated studies.
• Interpret and apply federal regulations (e.g., 45 CFR 46, 21 CFR 50/56), state laws, sponsor requirements, and institutional policies to study‑specific scenarios.
• Ensure studies remain compliant throughout the research lifecycle, proactively identifying and mitigating regulatory risk.
• Serve as regulatory lead for assigned studies, coordinating submissions and approvals across required regulatory review bodies.

Education

Bachelor’s degree in biological, social or physical science

Job description

Fred Hutchinson Cancer Center is seeking a Senior Regulatory Coordinator to provide advanced regulatory expertise for activation, maintenance, and compliance oversight of clinical studies. This role manages complex multisite trials and partners with investigators, IRBs, and sponsors to ensure timely, compliant study conduct.

The position supports regulatory staff, mentors coordinators, and helps with onboarding and training materials.