Sr. Regulatory Coordinator

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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.

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. The department of Clinical Research Support (CRS), the central clinical trials office for the University of Washington/Fred Hutch Cancer Consortium, seeks a Sr. Regulatory Coordinator to prepare documentation for industry‑sponsored, investigator‑initiated, and national cooperative group clinical trials.

This position supports our Phase I Oncology portfolio and is a hybrid role requiring two days on site per week.

• Serve as a central point of contact internally and externally for Phase 1 trials.
• Facilitate meetings and collaboration with key stakeholders.
• Prepare and submit regulatory documents to the IRB, including initial application, annual renewal, and modifications for industry‑sponsored, investigator‑initiated, and national cooperative group clinical trials.
• Establish and maintain Cancer Consortium and sponsor regulatory files.
• Create and maintain study‑related tools and templates for the startup and regulatory management of clinical trials.
• Prepare local consent forms from industry templates and for investigator‑initiated protocols; provide formatting and editing assistance for investigator‑initiated trial documents.
• Facilitate SAE processing to comply with FDA reporting requirements for IND trials.
• Liaise with investigators and study teams to ensure accuracy of documentation.
• Extract data from institutional databases to report study accrual data.
• Generate scheduled and ad hoc reports for ongoing safety data review and IND annual reports.

• Bachelor’s Degree in biological, social, or physical science or equivalent years of experience.
• 2 years of regulatory, clinical trials, and/or prevention study management experience.
• Previous experience with protocol design and review.

• Master’s degree.
• Experience writing technical documents.
• Clinical research related certification.
• Ability to communicate clearly, succinctly, and effectively over the phone and in writing.
• Knowledge of U.S. 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 time‑management skills.
• Advanced knowledge of MS Word and Acrobat.
• Excellent written and verbal communication skills.
• Effective organizational skills.

The annual base salary range for this position is from $80,475 to $120,682, and pay offered will be based on experience and qualifications. This position is not eligible for H‑1B sponsorship at this time.

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, on‑site 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), and paid parental leave (up to 4 weeks).

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans.

If due to a disability you need assistance or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops or by calling 206‑667‑4700.