Job Description

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 Cellular Immunotherapy Liaison will support Fred Hutch clinical research investigators in the implementation of Cellular Immunotherapy clinical trials at Seattle Children's (SC) and collaborate with the SC clinical research investigators and lead the implementation of cellular therapy research protocols in the assigned disease areas at SC. They will also create, manage and oversee research data and regulatory documents for the assigned SC Immunotherapy studies.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• In collaboration with immunotherapy faculty leadership, coordinate quarterly peds cellular immunotherapy meetings including preparing agendas, meeting materials, and ensuring any follow-up items from previous meetings are complete
• Define and document startup and implementation processes for adult cellular immunotherapy trials to be open at SC, and vice versa, partnering closely with the Fred Hutch-SC Liaison, and adult and peds immunotherapy managers
• Identify barriers to implementing immunotherapy trials across Fred Hutch and SC; troubleshoot and escalate cross-institutional challenges and barriers to research implementation and conduct through the Fred Hutch/Seattle Children's Research Affiliation Agreement (RAA) governance structure and appropriate SC and Fred Hutch immunotherapy team's structure
• Serve on Clinical Research Operations Sub-Committee (CROS) under the Fred Hutch/Seattle Children's Research Affiliation Agreement (RAA) governance as ad-hoc cellular immunotherapy representative
• Work across the Fred Hutch and SC immunotherapy programs; establish and maintain cross-institutional working relationships
• Participate in process improvement initiatives to identify barriers and implement resolutions for efficient and effective conduct of immunotherapy trials across the institutions
• Coordinate and monitor Affiliate Staff access applications and renewals for immunotherapy program staff to ensure appropriate access is maintained across institutions
• Oversee data and sample collection and sharing across institutions for correlative studies ensuring agreements and logistics support efficient and compliant workflows
• Facilitate startup and implementation activities across the institutions for immunotherapy trials
• Submit immunotherapy studies for intake at Fred Hutch and SC, initiate start-up and clinical readiness processes, monitor and resolve implementation-related queries leading to order validation and open to accrual
• Provide regulatory support for Fred Hutch Immunotherapy protocols open at SC
• Partner with study teams and service areas to resolve implementation issues and promote cross-institutional start-up efficiency
• Coordinate Research Group submissions and reviews for pediatric immunotherapy studies
• Triage new immunotherapy protocols for review requirements
• Attend Research Group meetings at both SC and Fred Hutch for immunotherapy trials
• Refer required trials to co-directors and work with study teams to coordinate reviews
• Work with co-directors and study PIs to facilitate implementation of studies for the Consortium's pediatric population in accordance with NCI mandates
• Oversee regulatory, budgetary, contractual, and all other aspects of protocol implementation, ensuring compliance with applicable institutional/departmental guidelines, federal regulations, and principles of Good Clinical Practice
• Supervise and prepare submission of IRB applications, renewals, and correspondence
• Prepare informed consents/assents and ensure that only currently approved versions are used
• Review selected protocols for feasibility for department participation; ensure protocol feasibility is completed and accurate; monitor to ensure division is in compliance with regulations, policies and procedures of granting agencies, Seattle Children's and the University of Washington
• Review protocol, determine appropriate tests and schedule of appointments based on research protocol;
• Assist the investigator in the determination of patient eligibility for studies
• Assist clinical staff in monitoring and reporting Adverse and Serious Adverse events
• Organize and participate with PI and research team members in Protocol Implementation and Study Initiation Meetings
• Provide oversight for, and generate, review and track clinical trial regulatory and data collection documents (source and CRF)
• Compile and organize research data, create research databases and perform consistency checks
• Communicate protocol/study related information and progress to PI and research team members
• Participate in site monitoring visits/audits
• Prepare written progress reports and protocol-related information; ensure study files are maintained in compliance with FDA, PHS and Seattle Children's guidelines analysis and evaluation consistent with patient confidentiality and HIPAA requirements
• Ensure IRB Renewals, protocol violations, adverse events, and research patient complaints/problems are promptly and clearly documented and communicated to the appropriate committees.
• Other duties as assigned.

Qualifications

• Bachelor's degree
• Five years of regulatory or clinical trials and/or study management experience.
• Ability to communicate effectively.
• Strong organizational skills.

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 $84,448 to $126,651, 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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700.

Job Tags

Holiday work, Flexible hours,

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