Regulatory Assistant

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.ResponsibilitiesAssist with preparation and submission of regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulationsMaintain study regulatory binders and files within electronic and/or paper binders by ensuring consistent filing of documents for ease of access within bindersManage and maintain protocol training documentsSupport 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 applicationsAssist in preparing and creating materials for monitoring visits; participate in visits as requestedAssist with follow-up and issue resolutions related to regulatory concerns identified during monitoring visitsAssist with the preparation and submission modifications/amendments and continuing renewals for ongoing study maintenanceReport noncompliance and unanticipated problems to IRB of recordSupport tracking and reporting of key metricsSupport central inbox maintenance and response/escalation to inquiriesSkillsHigh school diploma or equivalentAssociate's or Bachelor's degreeAbility 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 reportsAbility to use discretion and maintain confidentialityProficiency with MS Office suiteBenefitsMedical/visionDentalFlexible spending accountsLifeDisabilityRetirementFamily life supportEmployee assistance programOnsite health clinicTuition reimbursementPaid vacation (12-22 days per year)Paid sick leave (12-25 days per year)Paid holidays (13 days per year)Paid parental leave (up to 4 weeks)Company OverviewFred Hutch is an independent, nonprofit organization that also serves as the cancer program for UW Medicine. It was founded in 1975, and is headquartered in Seattle, WA, US, with a workforce of 1001-5000 employees. Its website is http://www.fredhutch.org.



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