Clinical Lab Scientist I

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 Pay Rate: $27-30/Hr Salary will be commensurate with candidate experience