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.

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 investigatorinitiated studies.
• Interpret and apply federal regulations (e.g., 45 CFR 46, 21 CFR 50/56), state laws, sponsor requirements, and institutional policies to studyspecific 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 auditready 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 crossfunctional alignment to meet activation timelines and compliance expectations.

MINIMUM QUALIFICATIONS:

• Bachelors 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).