Regulatory Coordinator II

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.

Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Regulatory Coordinator II is part of our central team providing regulatory support to Principal Investigators (PIs) and research study teams focused on mission‑critical clinical trials programs. The role will be responsible for regulatory management of trials, which may cover submissions in the study startup phase through closeout. The incumbent will report to the Assistant Director of Regulatory Operations.

This position will support our Phase I Oncology portfolio and is a hybrid position requiring two days on site weekly.

• 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.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.
• Minimum of two years of regulatory, human research protection or related experience in a research environment.
• Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.).
• Knowledge of FDA, GCP and NIH requirements,
• Ability to interpret and synthesize regulations and guidelines.
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem‑solving skills and the ability to reach and…