Sr. Regulatory Coordinator, eRegulatory Support

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 Hutchinson Cancer Research Center Cancer Consortium. The Sr. Regulatory Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials. The position will report to the CRS Director of Operations.

This is a remote position.

Responsibilities

• Assist with preparation, routing and mainteance of staff training and access for the eReguglatory system according to FDA regulations and internal policy. 
• Maintain training and guidance documents for study teams on system utilization, best practices and internal policies for eRegulatory binders and eConsent. 
• Manage and maintain staff training and permissions for eRegulatory system.
• Support study teams in building and optimizing their team binders within the eRegulatory platform.
• Supporting integration workflow solutations between eRegulatory and other workflows (CTMS, etc.)
• Assist in preparing and creating materials for data collection within the eRegulatory system, providing electronic source data solutions.
• Assist with follow-up and issue resolutions related to eRegulatory access and concerns identified by study …