Cures Start Here. AtFred 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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTNs mission is to facilitate the process of testing preventive vaccines against HIV/AIDS and related infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The Laboratory Center is responsible for carrying out the scientific agenda of the HVTN by conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.
The focus of responsibilities for the QA Associate II is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the HVTN Laboratory Operations Division. QA Associate I vs. II designation will be based on candidates qualifications and related experience.
The QA Associate will provide QA oversight to processing labs associated with HVTN clinical trials by:
Providing oversight for domestic and international network site labs for HVTN 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 HVTN 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.
Providing oversight for specimen processing and cryopreservation training and certification program.
Providing peripheral blood mononuclear cell (PBMC) External Quality Control program support including analysis, interpretation and reporting to sites. Review adequacy of site response on EQC reports.
Create additional quality assurance programs for other specimen types.
Collaborating with other divisions within the HVTN to support network clinical trials and representing the HVTN Lab Center in interactions with stakeholders.
Providing network lab support and training through regular site visits, 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 HVTN Laboratory Program and performing additional activities as necessary.
B.A./B.S. in a medical science field
Minimum 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
At least 5 years of experience as a medical laboratory scientist or equivalent strongly preferred
At least 1 year of laboratory experience focused in quality assurance
Understanding of HIV diagnostics testing
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
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.