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Fred Hutch · 1 day ago

Sr. Regulatory Coordinator

Seattle, WA

Full-time

Hybrid

Mid, Senior Level

$80K/yr - $121K/yr

2+ years exp

Fred Hutchinson Cancer Center is an independent, nonprofit organization focused on cancer treatment and research. The Sr. Regulatory Coordinator will prepare documentation for clinical trials, serve as a central point of contact for Phase 1 trials, and ensure compliance with regulatory requirements.

Hospital & Health Care

No H1B

Responsibilities

Serves as a central point of contact internally and externally for Phase 1 trials

Facilitates meetings and collaboration with key stakeholders

Prepares and submits regulatory documents to the IRB including initial application, annual renewal, and modifications for industry sponsored, investigator initiated, and national cooperative group clinical trials

Establishes and maintains Cancer Consortium and Sponsor regulatory files

Creates and maintains study-related tools and templates for the start-up and regulatory management of clinical trials

Prepares local consent forms from industry templates as well as for investigator initiated protocols; provides formatting and editing assistance for investigated initiated trial documents

Facilitates SAE processing to comply with FDA reporting requirements for IND trials

Liaises with investigators and study teams to ensure accuracy of documentation

Extracts data from Institutional databases to report study accrual data

Extracts data from study data bases for scheduled and ad hoc reports for ongoing review of safety data and IND annual reports

Qualification

Regulatory experienceClinical trials managementProtocol designTechnical document writingFDA regulations knowledgeIRB documentation reviewMS Word proficiencyAcrobat proficiencyCommunication skillsOrganizational skillsTime management skillsCollaboration skills