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.

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.

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 experience.
• Demonstrated ability to deliver outcomes in fast paced environments.
• Demonstrated ability to work as an effective member of an interdisciplinary team.
• Demonstrated skills in critical thinking and problem solving.
• Ability to process complex documents and extract key information.
• Working with multi-disciplinary teams.
• Forecasting and meeting deadlines.
• Communicating with all levels of a research organization.
• Basic knowledge of clinical trial budgets.
• Familiarity with project management tools and techniques.
• Familiarity with CTMS and systems to support workflow & metrics.
• Proficiency in use of Excel, MS Word, and Acrobat.
• Strong verbal and written communication skills.
• Strong attention to detail and ability to work according to CRS central office standards and best practices.
• Excellent interpersonal skills and ability to build positive and professional working relationships with internal and external stakeholders.
• Effectively able to communicate and demonstrate accountability in a remote setting.

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred.
• 1-2 years working in a regulatory environment.
• Master's degree.
• Experience writing technical documents.
• Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH).
• Experience reviewing IRB documentation and research protocols.
• Ability to work collaboratively and build relationships across a large organization.
• Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
• Excellent time management skills.
• Advanced knowledge of MS Word and Acrobat.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

The annual base salary range for this position is from $76,606 to $114,878, and pay offered will be based on experience and qualifications.
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).