Job Description: Position Clinical Laboratory Scientist – Research Lab Manager
Location: San Fernando Valley
Salary: $90,000 - $120,000 DOE
Client is a project-based lab that collects and tests clinical samples for research purposes. They manage between 20-40 sample collection and validation studies a year and have supported 120+ assays through the FDA (510K, PMA, and De Novo) and CE regulatory pathways.
The Clinical Laboratory Scientist and Lab Manager will lead validation projects -- approximately 5-10 projects a year, each lasting 3-10 months. You will manage 2 lab technicians, plan their runs, troubleshoot instrument issues as they arise, coordinate with lab partners and manage all communication with our clients.
* Manage validation tests for new assays, instrumentations and methodologies.
* Work with the sample collection team to source testing and supplies required for research specimens collected
* Work with our Chief Science Officer to generate performance qualification, method comparison, and validation reports.
* Manage lab inventory for new and existing projects.
* Troubleshoot instruments, methods, procedures, and in writing protocols and reports
* Recognizes abnormal test results and answers inquiries about them, the methodology, specificity, and sensitivity; answers questions about specific factors that can influence test results
* Communicate with clients, coordinate our activities with their other testing
* Resolve and troubleshoot all technical problems with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratory's performance standards
* Monitor and provide direct and constant supervision to laboratory technicians who are assisting in the testing process to ensure that they are performing only allowed procedures as defined in the Protocol, laboratory SOP and State and Federal Regulations.
* Ensure, implement, and support compliance with all departmental and company policies and procedures including but not limited to Quality and Safety
* Ensure that all documentation provided associated with test results, maintenance records, and quality control are detailed, accurate and legible
* Ensure that instruments are running at their optimum performance through routine and preventive maintenance
* Monitor performance of equipment by implementing QA and QC procedures.
* Monitor trends in service requests and implement corrective actions to improve operational efficiency and reduce downtime of the instruments.
* Assume supervisions/management of the laboratory in the absence of the Laboratory Supervisor, Technical Supervisor, General Supervisor and Laboratory Manager by giving direction, guidance to all personnel as necessary to complete testing and ensure all tasks are completed for the day.
* Assist in training and orientation of laboratory staff including but not limited to Clinical Laboratory Scientists, Laboratory Assistants, Phlebotomists, and other laboratory personnel
* Assist in performing staff competency assessments and annual staff performance reviews if needed.
* Assist in composing, reviewing, updating, and revising of new and current SOPs.
* Review monthly and annual instrument maintenance logs.
* Perform instrument performance/calibration verification, as needed.
Recruiting Points Credentials
* Bachelor of Science and/or equivalent training for California Clinical Laboratory Scientist License.
* Valid and Current Clinical Laboratory Scientist’s license issued by the State of California Department of Health Services, Required
* Minimum 4-years prior preferred experience in a clinical laboratory setting or related work environment to include: specialized and complex analysis, quality control, calibration, QC evaluation, inventory control, preventative maintenance, quality assurance and quality improvement activities.
* Previous experience and a working knowledge of Excel, Word, and Outlook
* Strong soft skills and organization skills required for clinical trial documentation – great communication, strong attention to detail, and client-service attitude
Specific Measures of Success – Expected Outcomes
* High quality testing conducted according to Protocol and well documented. The CLS will be responsible for overseeing and ensuring that testing is in accordance with the Clinical Trial Protocol and that the binder is well documented with all required documentation.
* A well-managed and organized lab including our sample biobank. The CLS will work with the sample collection team to bank valuable samples, keep the freezer organized and cataloged, and work on customer requests for banked samples.
* Strong coordination with sample collection team. The CLS will work with the sample collection team to ensure they are the lab supplies they need and that samples are processed and stored according to protocol
*You should know:* Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
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