Clinical Lab Scientist I

Position Title: Clinical Lab Scientist I

Work Location: Tucson, AZ, 85755

Assignment Duration: 12 Months

Work Schedule: First shift position (9:00 AM to 6:00 PM, M-F)

Work Arrangement: Onsite (laboratory setting)

Position 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.

Background & Context: Key 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.

Qualification & Experience:

* 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)

* 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.

* 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.

Working Conditions & Physical Demands (If Applicable): Additional Information (If Applicable): Experience in clinical trials preferred