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.
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) is the worlds largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. Most recently, the COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the HVTN to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus. The mission of CoVPN is to conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease.
The Clinical Quality Assurance Specialist position will coordinate the HVTN/CoVPNs Leadership Operations Center (LOC) Quality activities, which consists of maintaining all aspects of the quality program, ensuring compliance with industry guidelines and regulations, and overseeing the electronic Trial Master Files. The incumbent works under the direction of the HVTN/CoVPN Director of Quality & Regulatory Affairs with minimal direction.
Oversees the development and implementation of the Quality Management System, including but not limited to:
promoting a quality culture across the LOC
providing guidance and assistance to LOC staff on various aspects of the quality program, such as quality control activities
creating, maintaining and implementing Standard Operating Procedures (SOPs)
monitoring staff SOP training progress
tracking risk assessment needs and implementing the risk management program
monitoring issues and implementing the corrective and preventive action (CAPA) program and system
facilitating vendor audits
implementing internal audits
providing support for external audits
facilitating document control activities
implementing debarment checks
ensuring that quality records remain inspection ready
Oversees the development and implementation of electronic Trial Master Files (eTMFs) in Veeva Vault, including but not limited to:
creating and maintaining eTMFs
supporting system validations
performing quality control activities and internal audits of eTMFs
facilitating and monitoring staff training progress for Veeva Vault
Document procedures using Work Practice Guidelines, Job Aids, and checklists so others may fill in if needed
Support the Director of Quality & Regulatory Affairs in ongoing LOC Lean activities
Perform other tasks as assigned, including those related to Regulatory Affairs
BA/BS required, plus 2 to 4 years quality experience. Four years of progressive experience in implementing quality systems may substitute educational requirement.
Sharp critical thinking skills
High level of attention to detail and organization
Excellent written and verbal communication skills
Knowledge of Veeva Vault is highly desired
Experience in Lean methodologies is highly desired
Experience in clinical research is preferred
Knowledge of SharePoint, Blueworks, and SmartSheet is preferred
Good interpersonal skills and an ability to maintain confidentiality are essential
Demonstrated ability to work independently and take initiative in a dynamic environment
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism 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 email@example.com or by calling 206-667-4700.
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.