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Fred Hutch · 1 day ago

Regulatory Coordinator I

United States

Full-time

Remote

Entry Level

$28.36/hr - $40.37/hr

1+ years exp

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. The Regulatory Coordinator I will provide regulatory support to Principal Investigators and research study teams for clinical trials, managing regulatory documentation and compliance throughout the study lifecycle.

Hospital & Health Care

No H1B

Responsibilities

Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees, including drafting and reviewing content as appropriate

Submit all 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

Perform internal audit and quality assurance checks on regulatory documents

With input from PI(s), draft initial clinical research trial informed consent forms

Lead study start-up: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual

Prepare and present materials for monitoring visits; serve as primary point of contact during visits

Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits

Prepare and submit modifications/amendments and continuing renewals for ongoing study maintenance

Conduct study close-out

Process IND external safety reports; maintain documentation of PI review and submit/escalate safety reports as appropriate

Report non-compliance and unanticipated problems to IRB as applicable

Serve as primary regulatory resource for physicians, sponsors and study team, providing guidance on regulatory statuses, approvals and instructions regarding patient consent

Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.)

Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team

Identify, develop and implement any necessary revisions to related policies and procedures

Qualification

Regulatory guidelines knowledgeFDA knowledgeGCP knowledgeClinical Research Coordinator certificationResearch Professionals certificationPrior NIH experienceData reconciliationDiscretionMS Office proficiencyCommunication skillsProblem solving skillsConfidentiality