Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

Cell Therapy Clinical Trials Coordinator I

Job ID
18118
Type
Regular Full-Time
Company
Seattle Cancer Care Alliance
Location
US-WA-Seattle

Overview

The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.


The Cellular Therapy Lab (CTL) at the Seattle Cancer Care Alliance (SCCA) is on the cutting edge of new technologies for cancer therapy, including cell-based immunotherapy. We are committed to advancing treatment options for our patients through the translation of innovative research into clinical practice. We collaborate with our Alliance partners (University of Washington, Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital) as well as industry (biotechnology) and non-industry external entities.


CTL is responsible for all minimally manipulated therapeutic cell processing occurring at the SCCA for standard therapies, clinical trials and commercial cell therapeutics. Procedures range from cryopreservation to flow cytometric enumeration of cell proportions to more complex procedures such as cell selections, including enrichment and depletion. The laboratory is regulated by the FDA cGTP/cGMP standards, maintains College of American Pathologists (CAP) certification, and is accredited by the Joint Commission and FACT.


Employees must adhere to all SCCA policies and processes, including the SCCA Code of Conduct and all HIPAA privacy requirements.

 

Responsibilities

  • Based on review and synthesis of clinical trial/commercial product documents and existing CTL SOPs, draft SOPs specific for clinical trial and commercial products in CTL. Conduct and/or assign training as needed based on information gathered from sponsor product manual, protocol, and research team.
  • Represent Cellular Therapeutics (CTP) department in associated cell-based clinical trials with Alliance members and/or external sponsors to ensure successful implementation and maintenance as a part of the Clinical Trial Team in conjunction with guidance from CTP Management and Clinical Trial Operations Manager (CTOM).
  • Serve as a back-up Cellular Therapeutics representative for the CTOM for operational discussions, correspondence and committees, as required. This may include but is not limited to Operational Feasibility meeting, protocol implementation committee meeting, and cross-functional scheduling meetings. Communicate key outcomes from those meetings to the CTP Clinical Trial Team members, as needed.
  • Coordinate and facilitate activities related to the lifecycle of the clinical trial with guidance from CTOM. Activities include, but are not limited to maintenance of study-related documents, document revisions, training, scheduling, data collection, and coordination of processing and monitoring visits.
  • Review, research, and present literature associated with clinical trials technology and theory to staff.
  • Assist in coordination activities for the CTP Clinical Trial Team to handle implementation and maintenance activities, to track clinical trial status, activity and timelines.
  • In support of the CTP Clinical Trial Team, assist with the implementation of FDA approved cellular therapeutics (“commercial products”).
  • Provide technical service summaries to the Associate Director and Administrative Manager of CTP for contracting and finances, as needed.
  • Communicate with the Cell Therapy Medical, Scientific Directors and Administrative and Quality Associate Directors about clinical trials to seek or provide information, as needed.
  • Work with CTOM and CTL Management to learn about and address feedback from staff on issues or concerns regarding protocols.
  • Serve as a technical reference to assist with training and support operations
  • Responsible for knowledge of current FDA regulations or applicable accreditation standards in relation to applicable processes.

Qualifications

Required:

  • BA or BS in relevant major/field
  • 3+ years’ experience with cellular therapeutics, both theoretical and practical in the laboratory or 5+ years in biologics research and development and/or manufacture
  • Experience in the implementation of clinical trials and/or commercial products.
  • 2+ years lab coordination experience
  • Knowledge of basic hematology and immunology theory
  • Experience with magnetic bead-based cell selections, depletions
  • Experience reviewing clinical protocols, product manuals and other clinical trial/commercial product documents
  • Strong capabilities in training staff at a variety of levels
  • Experience writing and reviewing technical documents
  • Working knowledge of relevant regulations and standards, including cGTP and cGMP
  • High level of motivation and initiative
  • Ability to work independently, but also a member of a high-functioning team
  • Strong attention to detail
  • Collaborate and communicate effectively internally and externally across functions and organizations
  • Strong computer skills with proficiency in all MS Office programs


Preferred:

  • Experience in research and development, both academic and industry
  • Experience working with FACT and CAP accreditation standards
  • Experience in materials management
  • Process improvement, Six Sigma, Lean experience
  • Process development experience
  • Experience in facilitation of cross-functional projects
  • Project coordination or project management experience
  • Formal Project Management training, introductory or beyond
  • Experience with OneNote and Teams
  • Basic finance experience a plus

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.

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