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Laboratory Protocol Coordinator III/Supervisor, Vaccine Clinical Trials

Fred Hutchinson Cancer Center
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Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
 
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 
The HIV Vaccine Trials Network (HVTN) Laboratory Program is part of an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses to testing vaccine efficacy. The Laboratory Program is responsible for carrying out the scientific agenda of the HVTN in determining by laboratory based studies which vaccine regimens should be advanced for efficacy trials and show promise for licensure. This effort includes leading a number of working groups, committees, specimen repository oversight, assay performance and quality assurance.


Responsibilities

The Laboratory Protocol Coordinator III/Supervisor is a senior contributor who will manage a team that coordinates and supports the laboratory operations for HIV Vaccine Trials Network (HVTN) protocols (clinical trials). An individual in this role reports to the Director of Laboratory Operations but works with minimal day to day supervision. They will initiate critical tasks and demonstrate strong problem solving skills. The Laboratory Protocol Coordinator III/Supervisor will participate in HVTN conference calls and meetings, prepare written reports and oral presentations, and as necessary, assist with grant applications. They will coordinate with Statistical Center for HIV/AIDS Research and Prevention (SCHARP), protocol teams, clinical trial sites and study sponsors on protocol operations, data transfer, analysis and presentations. 
 
MAJOR DUTIES
  • Hire, train and supervise Laboratory Protocol/Operations Coordinators
  • Represent the HVTN Laboratory Program on protocol teams.
  • Establish immunological assays and corresponding specimen needs for each study.
  • Lead completion and maintenance of Central Assay Plan for each protocol.
  • Serve as laboratory protocol liaison to other protocol team members, Center departments, funding agencies, affiliated individuals or institutions, and outside organizations. 
  • Prepare operational plans for specimen collection and processing at the clinical research sites. Create study materials for laboratory-related procedures, including instructions and documents for the clinics and processing laboratories.
  • Contribute to case report form designs.
  • Prepare and maintain laboratory study cost estimates.
  • Participate in HVTN conference calls and meetings. Prepare written reports and oral presentations.
  • Facilitate communication between stakeholders to solve complex problems.
  • Troubleshoot operational details of clinical protocols with HVTN clinical and statistical groups.
  • Provide ongoing consultation on protocol laboratory related issues to protocol teams, network partners, sponsors and internal partners.
  • Monitor and work with clinical sites, including providing training, to ensure quality specimen collection and handling
  • Contribute to process improvement projects including but not limited to project working groups, updating template language and developing/updating work practice guidelines
  • Carry out complex projects. Set project goals and drive timelines to ensure that all activities are completed on time. Ensure clear internal, external and cross-unit collaboration and communication, including identification of milestones, issues & resolutions.
  • Increased involvement in downstream processes of protocol assay planning/oversight.
  • Carry out other complex responsibilities in support of the clinical trials and department needs.


Qualifications

  • PhD preferred, with 1 year experience with expertise in human clinical trials, immunology and/or virology is preferred. Or Master's/Bachelor's degree with 3+ years' experience with expertise in human clinical trials, immunology and/or virology plus 3 years of experience in the role of Laboratory Protocol Coordinator (or equivalent).
  • Experience in HIV-1 or SIV/macaque models a plus. Excellent written and oral communication is required.
  • Knowledge of T and B cell immunology and experience with immunological techniques such as flow cytometry is preferred
  • Personnel management experience preferred
  • Experience with MS Office.
  • Strong background in collaborative team leadership, project management and project completion.
  • Work under minimal supervision, and ability to create and manage project schedules, including tasks, deliverables, milestones and schedules.
  • Experience with GLPs and GCPs, CLIA and/or other laboratory certifications a plus.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through work at Fred Hutch is requested of all finalists.


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.