Clinical Lab Scientist I

CONTRACT

MUST HAVES:

• Must possess a BS or BA degree in a related discipline
• 1 year experience working in a clinical laboratory setting
• Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience

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.

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.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

Formal Training/Education:

Bachelor's Degree Must possess a BS or BA degree in a related discipline

Experience:

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.

Knowledge, Skills and Abilities:

• 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.

Travel Requirements:

As needed Based on business needs