QA Associate I/II - Infectious Diseases Clinical Research Consortium

Overview 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 Infectious Diseases Clinical Research Consortium (IDCRC) clinical trials network Laboratory Operations Unit is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The IDCRC's mission is to facilitate the process of testing candidate vaccines, diagnostics, therapeutics, and other interventions in clinical trials. The organization conducts Phase 1 through Phase 4 vaccine and treatment trials, including clinical studies in collaboration with industry partners. Responsibilities The focus of responsibilities for the QA Associate I/II is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the IDCRC Laboratory Operations Unit. QA Associate I vs. II designation will be based on candidate's qualifications and related experience. * The QA Associate will provide QA oversight to processing labs associated with IDCRC clinical trials by: * Providing oversight for domestic and international network site labs for IDCRC study preparation: providing site training, developing and communicating study-related lab practices and operations, and determining network lab equipment needs. The QA Associate will monitor Good Clinical Laboratory Practice compliance, workload, and other key quality indicators that may impact deliverables. * Providing input and support to other divisions within the IDCRC and client protocol teams for specimen processing, storage and shipping, as well as clinical lab testing/methodologies. * Facilitating implementation of specimen management programs for study related specimens including data entry and electronic systems support. * Review adequacy of site response on External Quality Assurance reports related to peripheral blood mononuclear cell (PBMC) processing. * Collaborating with other divisions within the IDCRC to support network clinical trials and representing the IDCRC Laboratory Operations Unit in interactions with stakeholders. * Providing network lab support and training through regular laboratory visits (virtual or physical), conference calls, or other appropriate media. Must be able to adapt communication styles based on targeted audience and topic. * Assisting site labs with implementation of individualized Quality Assurance plans and related QA systems, such as local document control and equipment maintenance programs. * Coordinating, participating in, and supporting the efforts of the IDCRC Laboratory Operations Unit and performing additional activities as necessary. Qualifications MINIMUM QUALIFICATIONS: * B.A./B.S. in a medical science field * Minimum requirement for QA-I level is 0-2 years of experience in clinical safety laboratory * Minimum requirement for Q-II level is 2-5 years of experience in clinical safety laboratory * Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance * Demonstrated experience in clinical safety laboratory management * Ability to work with minimal supervision PREFERRED QUALIFICATIONS: * At least 5 years of experience as a medical laboratory scientist or equivalent strongly preferred * At least 1 year of experience in quality assurance * Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials * Computer skills - including Microsoft Word, Excel, PowerPoint and laboratory-specific programs * Good numeracy, literacy and organizational skills * Good interpersonal communication and time management skills * Willingness to be flexible in working hours, be willing to travel as needed, and work some evenings and weekends * Fluency in Spanish Fred Hutch 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 provide proof of vaccination or initiate the accommodations process before their first day of employment. 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. 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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