Sr. Regulatory Coordinator

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

Overview

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

Responsibilities

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 approved budgets.

Leadership & Mentorship

• Serve as a subject matter expert and escalation point for regulatory questions.
• Provide training, guidance, and mentorship to Regulatory Coordinators and other research staff.
• Assist with onboarding and training materials related to regulatory processes.
• May lead or contribute to regulatory initiatives, policy updates, or working groups.

Collaboration & Communication

• Partners with investigators, study teams, budget and contracts staff, and operations to support efficient study activation.
• Communicate regulatory requirements clearly to stakeholders with varying levels of regulatory experience.
• Support cross‑functional alignment to meet activation timelines and compliance expectations.

Qualifications

MINIMUM QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

• Experience in oncology or academic research setting.
• Familiarity with NCI-sponsored trials, cooperative groups, or central IRB models.
• Experience with Oncore and electronic regulatory management systems.
• Certified Clinical Research Professional (CCRP), Certified IRB Professional (CIP) or similar certification.
• Demonstrated experience managing complex or multisite clinical trials.
• Strong working knowledge of human subject protection regulations, IRB processes, FDA regulations, GCP guidelines, and other applicable regulations.
• Ability to work independently, manage competing priorities, and meet deadlines in a fast-paced environment.
• Excellent organizational skills and attention to details.
• This is a majority remote position supporting a majority remote staff, must have effective written and verbal communication, troubleshooting, change management and conflict resolution skills within a remote setting.
• Proficiency in Word, SharePoint, Excel, Acrobat, OneDrive, CTMS.

The annual base salary range for this position is from $80,475 to $120,682, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well‑being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

Additional Information

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [e-mail] or by calling 206-667-4700.