Clinical Lab Scientist I

Job Title: Clinical Lab Scientist I Location: Oro Valley, AZ Type: Contract, Potential for extension or conversion to permanent Overview Responsible for performing high complexity laboratory testing on clinical specimens, interpreting and reporting results and complying with study protocols, Standard Operating Procedures, Test Instructions, and related CAP/CLIA Regulations and guidelines. Participates in scientific studies and activities supporting registrational and non-registrational clinical trials. Receives general instructions; plans and executes own work. Responsibilities Works under general supervision, to support aspects of clinical testing and sample processing, adhering to CAP/CLIA regulations and ISO 15189 guidelines. Performs high-complexity testing within the CDx CAP/CLIA Laboratory. Monitors performance of IHC, ISH, molecular assays, and immunoassays; assists with lab failure investigations and root cause analysis. Performs accessioning of biological samples (blood, plasma, tissue) and quality control of demographic data input. Communicates with clients on held and rejected samples. Performs work according to established internal safety guidelines and procedures, and as specified by appropriate regulatory agencies (SHE, OSHA) Critically evaluated quality control and test results against acceptance criteria to support clinical testing. Uses technical writing skills and Good Documentation Practices to complete lab documentation, SOPs, and Quality documents. Participate in routine lab maintenance and lab safety inspections. May perform basic troubleshooting for issues related to instrumentation. Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions; initiate and implement process improvements. Other duties as assigned by management. Requirements Bachelor's Degree Must possess a BS or BA degree in a related discipline - Required Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience. - Required Demonstrated proficiency in computer skills, such as word processing, statistical analysis, - Required laboratory information systems. - Preferred Excellent verbal and written communication skills. - Required Strong understanding of good laboratory practices and regulatory compliance. - Required Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules. Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.