Clinical QA Specialist, HVTN and CoVPN
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) is the world’s 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/CoVPN’s 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.
Responsibilities
- 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
Qualifications
- 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 hrops@fredhutch.org or by calling 206-667-4700.