Sr. Regulatory Coordinator

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.

Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Senior Regulatory Coordinator provides advanced regulatory expertise and leadership for the activation, maintenance, and compliance oversight of clinical research studies. This role independently manages complex, high-risk and multisite trials; serves as a subject matter expert on federal, state, sponsor, and institutional requirements; and mentors regulatory staff. The Senior Regulatory Coordinator partners closely with investigators, sponsors, IRBs, and institutional committees to ensure timely, compliant study conduct.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

This is a fully remote positon

Regulatory Oversight & Study Management

• 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.

Institutional & External Reviews

• Coordinate and prepare submissions for applicable committees and offices.
• Manage IRB reliance and authorization processes, including external IRB submissions (e.g., WCG, Advarra, NCI CIRB).
• Serve as a primary point of contact for IRBs and regulatory committees, responding to contingencies and stipulations.

Documentation & Systems

• Prepare, review, and maintain regulatory documents.
• Ensure accuracy and completeness of regulatory records in electronic systems (e.g., OnCore, Florence).
• Maintain audit‑ready regulatory files in accordance with institutional and sponsor standards.

Compliance, Risk, and Quality

• Identify regulatory compliance risks and recommend corrective or preventive actions.
• Support internal audits, sponsor audits, and regulatory inspections as needed.
• Contribute to continuous improvement efforts by identifying process gaps and recommending best practices.
• Ensure consent language aligns with regulatory requirements, institutional standards, and…