Regulatory Coordinator I

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 I will be responsible for supporting projects related to the regulatory operations of the Clinical Scholars (CS) research group of the Clinical Research Division (CRD). This position works under the supervision of the Program Director.

• Draft, distribute, and finalize Site Initiation Visit (SIV) minutes and attendance log 
• Process and file regulatory documents at the clinical site within required timelines while ensuring all applicable guidelines are followed
• Independently prepare IRB documents working with research teams and investigators to ensure forms are complete and provide accurate information for the IRB reviewers
• Perform electronic data entry and ensure all applicable electronic systems, including the clinical trials management system and electronic regulatory binder system, are updated within required timelines
• Collect and send staff qualifications, licenses, and training to institutional office for upload to the institution’s electronic storage platform
• Coordinate protocol-specific staff training and onboarding, ensuring completion of study-specific training, signatures, and delegation logs
  • Continuously update materials in accordance with protocol opening, protocol closure, and staff turnover
• Track and maintain correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees
• Track follow up letter receipt for monitoring, communicate with research teams to ensure responses to listed issues, and submit to institutional office according to established timelines
• Assist in the coordination of regulatory compliance activities with various stakeholders
• Perform internal audit and quality assurance reviews of regulatory documents, as directed by senior staff
• With assistance from senior staff, draft study consent forms for New IRB Applications
• Contribute to on-going enhancement of regulatory support activities
• Provide timely, clear, and professional communication
• Perform other responsibilities as assigned

Minimum Qualifications:

 

• High school diploma or equivalent and a minimum of one year of regulatory, human research protection or related experience in a research environment.
• Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.), knowledge of FDA, GCP and NIH requirements, ability to interpret and synthesize regulations and guidelines.
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills and the ability to reach and reconcile data in reports.
• Ability to use discretion and maintain confidentiality.
• Proficiency with MS Office suite.

Preferred Qualifications:

• Associate’s or Bachelor’s degree, Clinical Research Coordinator certification (CCRC) or Research Professionals certification (ACRP or SOCRA), prior experience working with NIH, FDA and OHRP regulations.

 

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 hourly pay range for this position is from $26.20 to $37.31 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 our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.