Sr. Regulatory Coordinator, Global Oncology

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The department of Clinical Research Support (CRS) is the central clinical trials office for the University of Washington/Fred Hutch Cancer Consortium. The Sr. Regulatory Coordinator, Global Oncolgy is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials. 

This is a remote position.

Responsibilities

• Supporting trials withing Global Oncology and other indications
• 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 …