Clinical Laboratory Technologist IV / V / VI #4836 #4837 #4838 #4839 #4840 #4841 ((Night Shift, Wed - Sat, 10:00pm - 8:30am)

The Clinical Laboratory Technologist performs a range of established laboratory procedures to support clinical and pre-clinical exploratory safety studies. The role contributes to the execution of assays, preparation and handling of samples, evaluation of test results, and accurate documentation of clinical research data. The position supports the coordination of routine study activities and maintains adherence to defined protocols, regulatory expectations, and laboratory quality standards within the Clinical Laboratory Technologist job family.

You will work on-site full-time at our office located in Durham, NC

• Perform testing activities according to established laboratory procedures, study protocols, and quality standards to support clinical research and safety study objectives.

• Prepare samples, reagents, materials, and work areas in accordance with defined workflows, ensuring accurate labeling, traceability, and compliant handling throughout the testing process.

• Operate and maintain laboratory instruments by performing routine checks, calibrations, and basic troubleshooting steps, and report equipment concerns to appropriate personnel.

• Record and verify test data in laboratory systems with accuracy and completeness, following defined documentation practices and data integrity expectations.

• Review assay results for consistency within expected ranges, identify routine inconsistencies, and escalate unusual findings to senior team members for further evaluation.

• Follow established procedures for quality control activities, including running controls, documenting deviations, and supporting routine review of quality trends.

• Support the coordination of study activities by ensuring appropriate sample flow, materials availability, and completion of required documentation according to defined requirements.

• Participate in verification activities for new equipment, procedures, or reagent lots by performing assigned tasks in accordance with established protocols.

• Maintain a clean and organized work environment by following laboratory safety, biosafety, and housekeeping practices required for regulatory readiness.

• Collaborate with team members by sharing information related to task progress, workflow timing, and procedural requirements to support consistent laboratory operations.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

• Bachelor’s degree in a life science field with relevant laboratory experience.

• ASCP MLS/MT or equivalent preferred.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: 

  • Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

  • Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)

  • Development and Operations within a regulated clinical study environment (e.g.  ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

• Proficiency in molecular testing workflows and basic troubleshooting.

• Strong time management skills to balance multiple test runs.

• Ability to coach less experienced team members.

• Working knowledge of CLIA/CAP documentation requirements.

• Laboratory environment with routine exposure to biological samples and chemicals.

• Requires frequent standing, walking, bending, and occasional lifting up to 40 lbs.

• Mandatory use of PPE (lab coats, gloves, safety glasses) at all times in laboratory areas.

• May require flexible work hours, including evenings, weekends, or holidays, to support operational needs.