Clinical Lab Scientist I

Responsibilities

• Perform high complexity laboratory testing on clinical specimens, interpret and report results, and comply with study protocols, Standard Operating Procedures, Test Instructions, and related CAP/CLIA Regulations and guidelines.
• Participate in scientific studies and activities supporting registrational and non-registrational clinical trials.
• Receives general instructions; plans and executes own work.
• 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 evaluates 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.

Requirements

• Bachelor's Degree: Must possess a BS or BA degree in a related discipline.
• Required 1 year of 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 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.