Regulatory Coordinator II

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 Regulatory Coordinator works in coordination with other Study Startup team members to perform comprehensive study startup support. The Regulatory Coordinator will be responsible for expeditious coordination of the regulatory submissions in the study startup phase to support key metrics reported to institutional leadership. At any given time, there will be 5 to 15 trials actively in startup. The incumbent will report to the Start-Up Operations Manager.

• Prepare and submit required internal and external submissions over the course of study startup and site activation. These include but are not limited to the submissions to an Institutional Review Board (central or local), the Institutional Biosafety Committee, the Radiation Safety Committee, and the Scientific Review Committee.
• Write informed consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent.  Must be able to explain complicated research protocol requirements to research participants using easily understood language.
• Integrate information from multiple sources and use specialized knowledge of institutional, state, and federal requirements to ensure compliance with those entities.
• Understand the timing and implications of other team members’ startup requirements to ensure accurate and effectively timed submissions.
• Liaise with investigators, industry sponsors, and study teams to ensure accuracy of documentation.
• Create, manage, and supply supportive documents such as 1572s, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and required training documentation.
• Create tools to support organized startup efforts to be used within the team, Clinical Research Support, and the Cancer Consortium.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree
• 3+ years working in clinical research environment (oncology preferred)
• Demonstrated ability to write informed consent documents
• Experience using central and local IRBs
• Ability to interpret and apply local, state, and federal requirements
• Demonstrated ability to work as part of an integrated team
• Demonstrated ability to deliver a high standard of work
• FDA, GCP, and NIH requirements relating to research involving human subjects  
• Strong organizational and document management skills
• Strong and effective verbal and written communication skills
• Strong analytical and problem-solving skills
• Excellent time management skills
• Advanced knowledge of MS Word and Acrobat

PREFERRED QUALIFICATIONS:

• Clinical research related certification

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.

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The annual base salary range for this position is from $67,728 to $99,237, 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). 

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. 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 are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.