Research & Development Institute, Inc.
  • Los Angeles, CA, USA
  • Full Time

Job Purpose

RDI Research & Development (RDItrials.com) is a project-based lab - we collect and test clinical samples for research purposes using immunoassay instruments that are not available in the market yet. Our company was founded in 2008 by a Scientist, and since then we have managed 125+ clinical trials where we collected and tested thousands of samples. The data we collect from our instruments is submitted to the FDA so that our clients can achieve 510K clearance. RDI manages 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.

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The Clinical Laboratory Scientist and Lab Manager will lead our 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 our lab partners and manage all communication with our clients.


You will also gain valuable experience in Clinical Research. You will be trained on the required research certifications (to the extent you do not have that already) and will be responsible for the Clinical Trial binder and passing the client & regulatory review processes (monitoring).


You will also manage our Van Nuys, CA lab, and ensure that all fridges, freezers, instruments, reagants, calibrations, and supplies are well taken care of. We are also in the process of applying for our CLIA accreditation and you will be instrumental in that process.

Responsibilities

□ 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, A MUST.

□ 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 Google Workspace.

□ 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 RDI conducts its testing 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



Research & Development Institute, Inc.
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