Clinical Lab Scientist I

Job Description

Job 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.

Duties and 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 aProductst 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 in Life Sciences (BA/BS)
• 1-3 years of experience in a clinical lab setting; histology or automated IHC experience preferred.
• Experience with Ventana Ultra Platform is a big plus.
• Demonstrates strong teamwork and adaptability, combining a willingness to follow direction with the self-motivation needed to deliver consistent results.

Preferred:

• Histotechnologist certification (HT or HTL).
• Experience working in a clinical laboratory, Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience.