The CDC Foundation helps the Centers for Disease Control and Prevention (CDC) save and improve lives by unleashing the power of collaboration between CDC, philanthropies, corporations, organizations and individuals to protect the health, safety and security of America and the world. The CDC Foundation is the go-to nonprofit authorized by Congress to mobilize philanthropic partners and private-sector resources to support CDC’s critical health protection mission. Since 1995, the CDC Foundation has raised over $1.9 billion and launched more than 1,300 programs impacting a variety of health threats from chronic disease conditions including cardiovascular disease and cancer, to infectious diseases like rotavirus and HIV, to emergency responses, including COVID-19 and Ebola. The CDC Foundation managed hundreds of programs in the United States and in more than 90 countries last year. Visit www.cdcfoundation.org for more information.
Position Highlights:
Position Title: Laboratory Director (CLIA)
Employment Classification: Part-time – ~5hrs/week
Location: Onsite – City of Chicago Laboratories
Position End Date: 09/30/2025
Salary: $51/hour
Overview:
The CDC Foundation urgently seeks candidates for a part-time Laboratory Director role assigned to the City of Chicago. Under administrative direction, this employee will function as the CLIA Director for 3 clinical laboratories under one CLIA certificate. The Laboratory Director is responsible for the overall operation and administration of the labs and must ensure the competency of all laboratory personnel. This employee will oversee the overall operation of a laboratory and will use extensive knowledge of moderate complexity laboratory analytical procedures on blood, body fluids, and samples related to public health investigations to train and assess laboratory staff.
Qualifications:
·Essential: Meets the qualifications for Laboratory Director in Laboratories Performing Moderate Complexity Testing as described by The Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA), which can be found at: https://www.ecfr.gov/current/title42/chapterIV/subchapterG/part493/subpartM/subjectgroupECFR10813e8157e2976/section493.1405
·Essential: Is not currently listed as CLIA Director on more than four (4) other CLIA Laboratory Certifications.
·Minimum of one (1) year experience functioning as the listed CLIA Director for a CLIA laboratory conducting moderate or high complexity testing.
·Clinical laboratory experience conducting moderate complexity microbiology, syphilis serology, and virology preferred.
·Minimum of bachelor’s degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution, including:
-Forty-eight (48) semester hours of medical laboratory science or medical laboratory technology courses; or
-Forty-eight (48) semester hours of science courses that include—
-Twelve (12) semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry;
-Twelve (12) semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and
-Twenty-four (24) semester hours of chemistry, biology, or medical laboratory science or medical laboratory technology in any combination.
·Certification by the American Society of Clinical Pathologists (ASCP) as a Medical Technologist, Medical Laboratory Specialist, Clinical Laboratory Technologist/Scientist, Specialist in Biology or equivalent preferred.
·High level of proficiency with manual clinical laboratory equipment, procedures, techniques, and quality control/assurance.
·Familiarity with appropriate handling of Hazardous waste materials such as chemicals and/or biohazardous materials and related safety, health, and environmental regulatory compliance standards, laws, and regulations, such as those from the Occupational Safety and Health Administration (OSHA), CLIA, CAP, FDA, EPA, etc.
·Experience working in a medical environment.
·Knowledge of and experience working with HIPAA Regulations and Compliance strategies, as well as maintaining confidential information.
·Experience with emergency response management and safety program management, utilizing written safety programs and safety training.
·Experience interpreting, applying, and adapting relevant regulations, policies, and procedures.
·Ability to exercise independent judgment to plan, develop, and conduct laboratory assignments within established procedural guidelines.
·Excellent verbal and written communication, including communicating orally in a clear, concise manner while tailoring the message to the intended audience; demonstrating courteous and cooperative behavior when interacting with the public, other agencies, and state staff; acting in a manner that promotes a harmonious and effective workplace environment.
·Experience researching, analyzing, and compiling data for reports.
Responsibilities:
·Responsible for fulfilling the requirements of a CLIA Laboratory Director for Laboratories Performing Moderate Complexity Testing which can be found at https://www.ecfr.gov/current/title42/section493.1407, and includes:
-Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;
-Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazard;
-Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart.
·Delegate CLIA Laboratory Director obligations as allowable by CLIA and appropriate; verify that all delegated duties are properly performed and identify remedial action if necessary.
·Must be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed.
·Conduct and appropriately document a minimum of one (1) on-site visit to each laboratory each month. These laboratories include:
-Lakeview Laboratory - 2849 N. Clark
-Austin Laboratory - 4909 W. Division
-Roseland Laboratory - 200 E. 115th Street
·Ensure that all documents required by CLIA and/or other relevant regulatory entities are available to all personnel and sign off on any changes to documents.
·Review laboratory standard operating procedures and sign off on changes.
·Review monthly quality control logs and designate remedial action as needed.
·Have a written list of responsibilities of each individual in the laboratory that specifies:
-The level of activity each is authorized to perform,
-Whether supervision is required for specimen processing, test performance or results reporting,
-Whether consultant or director review is required prior to reporting patient test results.
·Review and update the written list of responsibilities as needed.
·Ensure that the laboratory is enrolled in an approved proficiency testing (PT) program and review PT processes and results to ensure compliance.
·Review assessments and other documentation of laboratory processes to ensure that laboratory personnel are performing the test methods as required to obtain accurate and reliable results.
·Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to verify that they maintain competency in the skills below and, whenever necessary, identify remedial training and/or continuing education needed to improve skills.
-Process specimens,
-Perform test procedures,
-Report test results promptly and proficiently.
·Ensure that a CLIA-qualified general supervisor provides onsite supervision of testing personnel.
·Identify and verify completion of remedial action as needed for processes, systems, documentation, and/or testing personnel that do not meet the standards set by CLIA and/or other relevant regulatory entities.
Special Notes:
This role is involved in a dynamic public health program. As such, roles and responsibilities are subject to change as situations evolve. Roles and responsibilities listed above may be expanded upon or updated to match priorities and needs, once written approval is received by both the CDC Foundation and the Chicago Department of Public Health, in order to best support the State of Illinois in their public health programming.
This position is currently onsite. CDC Foundation retains the right to make adjustments to this as required.
The CDC Foundation is a smoke-free environment.
Relocation expenses are not included.
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All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, national origin, age, mental or physical disabilities, veteran status, and all other characteristics protected by law.
We comply with all applicable laws including E.O. 11246 and the Vietnam Era Readjustment Assistance Act of 1974 governing employment practices and do not discriminate on the basis of any unlawful criteria in accordance with 41 C.F.R. §§ 60-300.5(a)(12) and 60-741.5(a)(7). As a federal government contractor, we take affirmative action on behalf of protected veterans.
The CDC Foundation is a smoke-free environment.
Relocation expenses are not included.
