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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
