Seattle Cancer Care Alliance brings together the leading research teams and cancer specialists of Fred Hutch, Seattle Children's and UW Medicine. One extraordinary group whose sole mission is the pursuit of better, longer, richer lives for our patients.
Seattle Cancer Care Alliance is ranked among the top ten cancer hospitals in the nation by U.S. News & World Report. Our care combines powerful science with devoted collaboration.
Above all, we exist to move patients forward, past boundaries and toward hope.
The Research Integration Quality Assurance (QA) Specialist coordinates and manages QA activities associated with industry sponsored, investigator initiated and NCTN clinical research studies that include, but are not limited to, the review of all trial-related activities and documents to assure compliance with the protocol plan, internal policies, standard operating procedures (SOPs), good clinical practices (GCPs) and all other relevant regulations. The QA Specialist will work closely with Research Integration (RI) leadership and staff, sponsors and Principal Investigators to address compliance challenges and issues. In this position, the incumbent will be responsible for developing and implementing a comprehensive quality assurance program in the context of clinical trials management. He/she will build a culture of excellence and compliance with the goal of achieving an audit ready operation at all times.
The incumbent performs all duties in a manner that promotes the mission, values, and philosophy of the Seattle Cancer Care Alliance. In all aspects, he/she serves as a role model for the values and mission of the organization.
Principal duties and Functions:
STANDARDS OF PERFORMANCE:
Each of these are considered an essential function:
Bachelor’s degree in a health related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent professional experience.
A minimum of 5 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function required.
Knowledge, Skills, and Abilities