Remote Senior Regulatory Lead for Clinical Trials

Life Science Washington; Seattle (WA); Remote; USD 80,000 - 121,000; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle (remote) seeks a Senior Regulatory Coordinator to lead regulatory activities for complex clinical trials. You will oversee startup, amendments, continuing reviews, and closeouts, ensuring compliance with federal and state rules and sponsor requirements.

The role requires in-depth knowledge of IRB processes, regulatory submissions, and experience with OnCore and Florence regulatory systems.

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.
• Interpret and apply federal regulations (45 CFR 46, 21 CFR 50/56), state laws, sponsor requirements, and institutional policies.
• Ensure studies remain compliant throughout the lifecycle, identifying regulatory risk.
• Serve as regulatory lead for assigned studies, coordinating submissions and approvals across required regulatory bodies.
• Coordinate and prepare submissions for committees and offices.

Skills

Regulatory leadership

Clinical trials experience

IRB processes

Regulatory submissions

Education

Bachelor's degree in biological, social or physical science

Tools

OnCore

Florence

Job description

Fred Hutchinson Cancer Center in Seattle (remote) seeks a Senior Regulatory Coordinator to lead regulatory activities for complex clinical trials. You will oversee startup, amendments, continuing reviews, and closeouts, ensuring compliance with federal and state rules and sponsor requirements.

The role requires in-depth knowledge of IRB processes, regulatory submissions, and experience with OnCore and Florence regulatory systems.