Senior Regulatory Lead - Remote Clinical Trials

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

Benefits offered by this job

Medical insurance

Dental insurance

Flexible spending accounts

Life insurance

Disability insurance

Retirement plan

Employee assistance program

Onsite health clinic

Tuition reimbursement

Paid vacation

Paid sick leave

Paid holidays

Paid parental leave

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Senior Regulatory Coordinator to provide advanced regulatory expertise for activation, maintenance, and compliance oversight of complex clinical trials. You will mentor staff and partner with investigators, sponsors, IRBs, and committees to ensure timely, compliant study conduct.

The role is primarily remote, supporting a distributed team across sites. A strong background in regulatory affairs, clinical trials, and IRB processes is required,

Qualifications

• Bachelor's degree in biological, social or physical science (or equivalent).
• Two years of regulatory or clinical trials experience.
• Experience with protocol design and review.

Responsibilities

• Independently manage regulatory startup, amendments, continuing review, and closeout for moderate to highly complex trials.
• Interpret and apply federal, state, sponsor, and institutional requirements to study scenarios.
• Ensure ongoing compliance and identify regulatory risks throughout the lifecycle.
• Coordinate submissions and approvals across required regulatory review bodies.

Skills

Regulatory expertise

Clinical trials

IRB processes

Documentation

Regulatory submissions

Education

Bachelor's degree in biological, social or physical science

Tools

OnCore

Florence

CTMS

Excel

SharePoint

Job description

Fred Hutchinson Cancer Center in Seattle is seeking a Senior Regulatory Coordinator to provide advanced regulatory expertise for activation, maintenance, and compliance oversight of complex clinical trials. You will mentor staff and partner with investigators, sponsors, IRBs, and committees to ensure timely, compliant study conduct.

The role is primarily remote, supporting a distributed team across sites. A strong background in regulatory affairs, clinical trials, and IRB processes is required,