GENERAL STATEMENT OF RESPONSIBILITY: Responsible for the overall operation and administration of the General Laboratory.
Ensure that the Laboratory complies in every way with applicable state licensure laws, accreditation standards and federal certification standards, including but not limited to the applicable requirements under the laws of the States of Kansas and New York, the CLIA requirements, and CAP and all applicable ISO standards to include but not limited to ISO 15189 and ISO 17025. Maintain direct contact with CAP affiliate in order to make inquiries regarding upcoming changes to and interpretations of CAP requirements and related regulations.
Ensure that the testing systems / platforms in the laboratory provide quality services in all aspects of test performance (pre-analytic, analytic, and post-analytic phases of testing) and their appropriateness for the intended population.
Participate in i) the consideration of appropriate test methodology, instrumentation reagents, standards and controls, ii) the design of test protocols and the establishment of parameters for the performance of test, iii) the establishment of test reference values and levels of precision, accuracy, efficiency, specificity and sensitivity, and iv) the review and approval of validation packets and data, at or above current standards of practice and/or established benchmarks of performance.
Ensure that records are properly maintained, including as required by applicable state and federal rules and regulations and in accordance with established benchmarks for performance.
Assist in all regulatory reviews in accordance with timelines established as benchmarks for performance and in development of protocols and guidelines that are quality based and that promote standardization, cost effectiveness, customer satisfaction, and efficiency.
Assist in the design, implementation and oversight of the Laboratory’s quality management system.
Provide direction in the performance and evaluation of quality improvement and quality control procedures.
Work in collaboration with CRL’s operations team to operationalize scientific and quality management goals.
Assist in the preparation of financial budget recommendations.
Make recommendations with respect to staffing levels, education and qualifications of personnel and assist in continuing education, performance evaluations and recruitment.
Assist in assuring that tests, examinations and procedures are properly performed, recorded and reported. Provide test result interpretation as needed and recommendations regarding appropriate follow-up test.
Provide direction in the evaluation of clinical laboratory data and the establishment of a process for review of the test results prior to the issuance of reports.
Oversee the establishment of and adherence to turnaround times and the criteria for critical and panic levels, according to the benchmarks and/or standards of practice agreed upon.
Assist in the prioritization of testing and testing sequence. Assist in the determination of and adherence to formats for reporting.
Assist in the determination of the type of data collection and storage criteria to be used for particular test.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks, participating in professional societies.
Be available to answer scientific/technical questions for various CRL clients.
Consult with customers/sponsors on testing requirements and testing methods for specific studies.
Oversee the development and implementation of new laboratory assays.
Maintain and protect the confidentiality of all CRL and client information.
Be able to comply with all applicable federal, state, and local safety and health regulations that would apply to this job.
Other duties as assigned
denotes essential job function
Ph.D., M.D. or equivalent - must have credentials required to obtain a medical license in the State of Kansas and/or with the following:
Board certified by the American Board of Clinical Chemistry (DABCC) and/or the American Board of Pathology (in Clinical Pathology)
2 years of experience directing or supervising high complexity testing in a clinical chemistry laboratory
Ability to meet CAP requirements as high complexity laboratory director required; current CAP certification preferred
Current NYSDOH Certificates of Qualification (CoQ) for clinical laboratory testing or eligible for such
SKILLS & ABILITIES:
Thorough knowledge of CAP, CLIA, and New York State regulatory requirements preferred.
Broad knowledge of laboratory operations to include expertise in method validation and laboratory developed tests.
Ability to work independently
Problem solving and analytical ability
Excellent verbal and written communication skills
Excellent Supervisory skills including interpersonal relationship skills
Strong computer skills
Strong organizational skills
Sound judgment and decision-making skills
Works well under pressure
Lifting up to 25 lbs.
EQUIPMENT: PC and communications equipment; basic laboratory equipment
OTHER: May require overnight travel; night and weekend work as necessary.
denotes essential job function
Internal Number: 6117
About Clinical Reference Laboratory, Inc
Established in 1979, CRL offers leading-edge testing services in the areas of Toxicology, Corporate Wellness, Insurance, Clinical Trials, Molecular Diagnostics, and BioAnalytics — all under one roof at our 192,000 square foot, state-of-the-art facility in Lenexa, Kansas. With a comprehensive test menu ranging from routine laboratory services to the latest in molecular testing, we are committed to providing high quality science with a human touch.
Over 500 employees strong and continuing to grow
Over 4,000,000 samples processed a year; capacity of over 25,000 samples daily
Over 80,000,000 tests analyzed annually
95% of samples processed within 24 hours — the most rapid turnaround time in the industry
Unparalleled customer service and responsiveness
Ongoing technical innovation that directly benefits your bottomline