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Fred Hutch · 5 days ago

Regulatory Assistant

Seattle, WA

Full-time

Hybrid

New Grad, Entry Level

$25.72/hr - $36.62/hr

Fred Hutchinson Cancer Center is an independent, nonprofit organization focused on cancer treatment and research. The Regulatory Assistant will support regulatory compliance measures and clinical trials by assisting with regulatory submissions, quality control, and compliance issue resolution as part of the Central Regulatory team in Clinical Research Support.

Hospital & Health Care

No H1B

Responsibilities

Assist with preparation and submission of regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations

Maintain study regulatory binders and files within electronic and/or paper binders by ensuring consistent filing of documents for ease of access within binders

Manage and maintain protocol training documents

Support Principal Investigators (PIs) and Regulatory Coordinators by reviewing drafted trial materials (e.g. informed consent forms)

Assist with study start-up by preparing required regulatory documents for new study applications

Assist in preparing and creating materials for monitoring visits; participate in visits as requested

Assist with follow-up and issue resolutions related to regulatory concerns identified during monitoring visits

Assist with the preparation and submission modifications/amendments and continuing renewals for ongoing study maintenance

Report noncompliance and unanticipated problems to IRB of record

Support tracking and reporting of key metrics

Support central inbox maintenance and response/escalation to inquiries

Qualification

Regulatory complianceClinical trials supportMS Office proficiencyData reconciliationProblem-solving skillsWritten communicationVerbal communicationConfidentiality

Required

High school diploma or equivalent

Preferred

Associate's or Bachelor's degree

Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem-solving skills, and the ability to review and reconcile data in reports

Ability to use discretion and maintain confidentiality

Proficiency with MS Office suite