Senior Regulatory Lead, Remote Clinical Trials

careers-fhcrc; Seattle (WA); Remote; USD 80,000 - 121,000; Full time

Benefits offered by this job

Remote work

Competitive benefits

Tuition reimbursement

Paid time off

Job summary

Fred Hutchinson Cancer Center in Seattle/remote-eligible role seeks a Senior Regulatory Coordinator to lead regulatory oversight for complex multicenter trials. You will act as a subject‑matter expert, mentor staff, and partner with investigators, sponsors, and IRBs to ensure compliant study conduct.

The role emphasizes independent management of regulatory activities, risk mitigation, and partnership across institutional review processes in a majority remote setting with a robust benefits

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 complex trials.
• Interpret and apply federal and state regulations to study-specific scenarios.
• Ensure ongoing compliance and proactively identify and mitigate regulatory risk.
• Lead regulatory submissions and approvals across required review bodies.
• Coordinate submissions for committees and IRB reliance processes.
• Maintain regulatory documents and audit-ready files in electronic systems.
• Support internal audits, sponsor audits, and regulatory inspections as needed.
• Provide training, guidance, and mentorship to regulatory staff.
• Communicate regulatory requirements clearly to stakeholders.
• Collaborate with investigators and study teams to meet activation timelines.

Skills

Regulatory coordination

Clinical trials

FDA regulations

IRB submissions

Study oversight

Education

Bachelor's degree in biological, social or physical science

Tools

OnCore

Florence

Word

SharePoint

Excel

CTMS

Job description

Fred Hutchinson Cancer Center in Seattle/remote-eligible role seeks a Senior Regulatory Coordinator to lead regulatory oversight for complex multicenter trials. You will act as a subject‑matter expert, mentor staff, and partner with investigators, sponsors, and IRBs to ensure compliant study conduct.

The role emphasizes independent management of regulatory activities, risk mitigation, and partnership across institutional review processes in a majority remote setting with a robust benefits