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 Regulatory Coordinator is responsible for preparing and processing submission documentation for clinical trials and investigator-initiated clinical research. The position will prepare FDA, IRB and IBC documents and other study-related tools for the start-up and management of clinical research, maintain regulatory files, and facilitate onsite processing at the Vaccine Trials Unit clinical location(s).

Responsibilities

• Provides regulatory support to investigators and staff throughout the lifecycle of a clinical trial or clinical research protocol
• Writes, prepares and submits complex IRB/IBC submissions including applications, renewals, amendments, consent forms, safety reports, etc. in accordance with required timelines
• Prepares and coordinates site registration (RSC) materials/submissions and assist with communications with sponsors
• Develops internal processes, tools/templates, and standard operating procedures for the clinical research team
• Along with the PI and Regulatory Manager, tracks all clinical activity documents for the Vaccine Trials Unit (VTU) including IRB/IBC/RSC approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
• Assures the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments
• Assists in the coordination of project activities to ensure they follow timelines and meet deadlines
• Assists in the development of research materials
• Performs information searches related to studies and projects
• Provides clear and concise professional communication
• Uses judgment to interpret and apply federal and local regulations regarding clinical research
• Performs other responsibilities as assigned

Qualifications

REQUIRED

• High school diploma or equivalent
• Minimum of one year of regulatory, human research protection or related experience in a research environment
• Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
• 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
• Skilled in the use of clinical trials and electronic document management systems

PREFERRED

• Associate's or Bachelor's degree in a related field
• 2-3 years working in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting
• Regulatory and/or Clinical research-related certification (RAPS, ACRP, SOCRA)

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment: Provide proof of being fully vaccinated against COVID-19 ; ORInitiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider's 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.

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).

Our Commitment to Diversity

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.