Clinical Lab Scientist I

Position Title: Clinical Lab Scientist I

Work Location: Tucson, AZ, 85755

Assignment Duration: 12 months

Work Arrangement: 9:00 AM to 6:00 PM, M-F (Onsite)

Position Summary:

• 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.

Key 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.

Qualification & Experience:

• Bachelor's Degree Must possess a BS or BA degree in a related discipline
• 1 year experience working in a clinical laboratory
• Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience.
• Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems.
• Excellent verbal and written communication skills.
• Strong understanding of good laboratory practices and regulatory compliance.
• Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules.