Clinical Laboratory Senior Scientist

Overview

Job specifications are intended to present a descriptive list of the range of duties performed by employees. Specifications are not intended to reflect all duties performed within the job. The employer retains the right to change or assign other duties to this position.

Essential functions are intended to present a descriptive list of the range of duties performed by employees. This list of essential functions is not intended to reflect every duty that may be performed within the job.

• Serves as the Clinical Laboratory Senior Scientist for high-complexity labs analyzing samples under the specialty of Microbiology/subspecialty-Virology accredited under the Clinical Laboratory Improvement Program (CLIP).

• Provide full time on-site support to be available to the laboratory and provide oversight and recommendations/guidance as specified in this PWS.

• The Clinical Laboratory Senior Scientist is responsible for the selection of the test methodology that is appropriate for the clinical use of the test results.

• Establish a quality control program appropriate for the testing performed and establish the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.

• Identify training needs and assure that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.

• Provide feedback to the Government on the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, feedback must be provided to the Government at least annually unless test methodology or instrumentation changes, in which case, prior to reporting sample results, the individual’s performance must be reevaluated by the Government to include the use of the new test methodology or instrumentation.

• Provide information to the Clinical Lab Director as requested

• As requested, produce/compile/present data from samples analyzed by the lab to answer questions being put forward to support DA and DoD guidance and Senior Leader needs

• Maintain direct mentorship and provide daily feedback to the technical individuals conducting the tests

• The Clinical Laboratory Senior Scientist is responsible for the technical and scientific oversight of the laboratory through feedback provided to the Government.

• Responsible for the validation or verification of the test procedures performed and establishment of the laboratory’s test performance characteristics, including the precision and accuracy of each test and test system.

• Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.

• Ensuring that sample results are not reported until all corrective actions have been taken and the test system is functioning properly.

• Verifying the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to—

• Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;

• Monitoring the recording and re- porting of test results;

• Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;

• Direct…