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 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 Statistical Center for HIV/AIDS Research and Prevention (SCHARP ) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Computer Systems Validation Specialist. The Computer System Validation Specialist uses best practices to develop, conduct, and document validation of clinical research systems in accordance with federal guidance on computer systems validation. This role works with Business Analysts, Developers, and Project Managers within an agile SDLC to ensure that computer systems function as designed in a consistent and reproducible manner, and meet business, functional, and regulatory requirements. This role reports directly to the Associate Director, Technology Systems & Services.
The person in this position is responsible for leading or contributing to the planning and documentation of computer system validations. They will also participate as a Tester in developing, maintaining, and conducting system and integration testing for SCHARP systems, in support of computer system validation. In addition to testing, they will be responsible for developing and maintaining a system test methodology and computer system validation procedures that complements the SCHARP SDLC. Tests, test methodology, and computer system validation artifacts will be thoroughly documented according to best practices. This person will work as part of project and validation teams, responsible for writing and conducting tests, as part of system upgrade teams, responsible for conducting regression testing, and independentlyand proactively developing test methodology, and improving computer system validation practices.
Responsibilities may include:
Develop, document, implement, and grow system test and computer system validation methodology in alignment with best practices and regulatory guidance
Develop and maintain system test plans that include grey and black box testing of both in-house developed and COTS systems
Conduct and document computer system validations, and ensure that validation artifacts, including validation plans, requirements documents, risk assessments, traceability matrices, are accurate and documented correctly
Write, document, and execute system Operational Qualifications (OQ) as part of computer systems validation
Conduct system and integration and regression testing and document results
Play the role of Quality Assurance / Test for assigned applications as part of an agile SDLC
2+ years of experience in test
Direct experience with computer systems validation
Direct experience with software testing methods and processes
Strong communication and documentation skills
Able to define clear and concise processes
Must be team-oriented and collaborative
Bachelors Degree in Computer Science, Computer Information Systems, Informatics or related field
Experience working in a clinical research environment
ITIL experience or certification
Experience with test automation frameworks and tools
Experience querying database systems
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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.