Clinical Lab Scientist I

Job Title

Job Overview: Pay Range: $30.00hr - $32.00hr Requirement/Must Have:

• 1+ years of experience.
• Strong understanding of good laboratory practices and regulatory compliance.
• Excellent attention to detail.
• Ability to multi-task and be flexible with tasks and schedules.
• Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems.

Responsibilities:

• 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.
• 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 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 (Candidate, 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.
• Participates 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.

Nice to Have:

• Experience in clinical trials preferred.

Skills:

• Clinical Laboratory Testing.
• CAP/CLIA Regulations.
• ISO 15189.
• IHC.
• ISH.
• Molecular Assays.
• Immunoassays.
• Accessioning.
• Technical Writing.
• Good Documentation Practices (GDP).
• Laboratory Information Systems (LIS).
• Statistical Analysis.

Qualification And Education:

• Strong verbal and written communication skills.