• Clinical Trial Manager, Immunotherapy

    Job ID 2020-34479
    Area of Interest
    Research & Development
    Location Name
    Metropolitan Park West
    FTE/Hours per pay period
    1.0 FTE (80 hours per bi-weekly pay periods)
    Work Status
    Regular
    Department
    Immunotherapy Integration Hub
    Shift
    Day Shift
    Primary Location : City
    Seattle
    Primary Location : State/Province
    WA
  • About Us

    Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible.  Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE

     

    As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

     

    Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine. 

     

    Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report’s top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems.

     

    We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.

    Overview

    We need your deep experience in clinical trial operations and drug development to further our mission to provide cutting edge therapy to kids! We are a growing organization of trial and data management, biostatistics, regulatory, and clinical development professionals supporting bench to bedside research and care in a fast-paced environment.  You will join a team which coordinates and manages the planning, implementation, and completion of single and multi-site clinical trials for Seattle Children’s Immunotherapy Integration Hub. Ensure research projects are conducted in compliance with applicable federal and local regulations, ICH/GCP, organization policies, and institutional/ departmental guidelines. Manage clinical sites, resources, and vendor(s) as applicable. Oversee data monitoring and monitor as required. Develop and maintain study documents including protocols, plans, manuals, subject materials and forms. Train and mentor junior staff. Ensure trials meet determined timelines for key milestones and deliverables. Identify and implement process improvement ideas in collaboration with department staff. Assist with development of department infrastructure as required. Bring your joy, patience, and sense of humor!

     

    Seattle Children's Employer Highlights:

    - Leader in Pediatric Care: Because of our people, Seattle Children’s is recognized as a leading teaching, research and specialty care center at the forefront of pediatric care.

    - Competitive Benefits: We support a healthy work–life balance. Our benefits include employee care, paid time off, health insurance and retirement savings.

    - Transportation Discounts: Company bike program, on-site zip cars, unlimited ORCA transit pass, daily commute bonus provided to staff who us alternate methods of travel to/from work, company vanpools.

    - Diversity/Inclusion: We strive to maintain an atmosphere that reflects our values of inclusion by providing effective and respectful care compatible with each patient and family's beliefs, values, and heritage.

    Requirements

    Required Education/Experience:
    - Bachelor’s Degree in biological sciences or health-related field.
    - Minimum of five (5) years’ experience as a clinical research associate or equivalent position, including at least two (2) years managing clinical studies for a sponsor organization, or equivalent application of research methodology in a clinical research setting.
    - Experience leading teams in a matrixed environment.
    - Experience in Phase 1 & 2 clinical research.
    - Experience developing study materials (eg, protocols, plans, manuals).
    - Experience evaluating site performance against established criteria.

    Preferred:
    - Seven (7) years of related experience in an FDA-GCP regulated industry.
    - Clinical Research Associate certification.
    - Masters Degree in biological sciences or health-related field.
    - Experience managing complex oncology clinical trials.
    - Experience managing vendor(s), eg,Contract Research Organization (CRO).
    - Experience managing pediatric clinical trials.
    - Experience working in an academic setting.
    - Experience working with Lean or Six Sigma principles.

    Our Commitment to Diversity

    Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

     

    The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.

     

    Seattle Children’s is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.

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