Sr. Regulatory Coordinator

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. 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.

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. 
• 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. Primary portfolio to potentially include Breast Oncology, Global Oncology and/or other disease teams. 
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations. 
• Creates and maintains study-related tools and templates for the start-up and regulatory management of clinical trials.
• Establishes and maintains Cancer Consortium and Sponsor regulatory files.
• Liaises with investigators and study teams to ensure accuracy of documentation.
• Perform internal quality assurance checks on regulatory documents. 
• With input from PI(s), draft and edit clinical research trial informed consent forms. 
• 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, SAE and unanticipated problems to IRB as applicable. 
• 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.
• Serve as a mentor to junior staff supporting cross-department development. 
• 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. 

Qualifications

MINIMUM QUALIFICATIONS:

• Minimum 2 years’ experience coordinating clinical trials, preferably oncology trials.
• Bachelor’s Degree in biological, social or physical science.  or equivalent years of exper