Analytical Specialist - Clinical Transplantation Immunology Laboratory

Duke Careers•Durham, NC

89d•Hybrid

About The Position

Duke University Health System Clinical Laboratories is seeking an Analytical Specialist for the Clinical Transplantation Immunology Laboratory (CTIL) at Duke University Hospital. CTIL is vital to Duke’s renowned transplant programs, supporting nearly 800 transplants annually across solid organ and bone marrow services. The laboratory is recognized for its clinical excellence and engagement in cutting-edge research, including clinical trials. This role involves administering and coordinating technical activities within a specific segment of the Clinical Laboratories to ensure effective technical operation. The laboratory is accredited by the College of American Pathologists and certified by the Clinical Laboratory Improvement Amendments.

Requirements

Bachelor's degree in Medical Technology or related field.
Minimum of 5 years of experience in an ASHI accredited HLA laboratory.
Certification in Medical Technology by a nationally recognized agency/board and/or in the specialized field of the assigned Lab.
Assignment in Transfusion Service requires certification as a Specialist in Blood Banking (SBB).

Nice To Haves

Minimum educational or experience requirements may be modified on a case-by-case basis at the discretion of the CLIA (Clinical Laboratory Improvement Amendment) director as long as minimal CLIA requirements are met by the employee for the tasks being performed.

Responsibilities

Perform final review of high-complexity HLA laboratory testing and analysis.
Ensure accuracy and integrity of test results in compliance with regulatory standards.
Collaborate with laboratory scientists and clinical teams to support transplant decision-making.
Participate in quality improvement initiatives and laboratory development activities.
Administer and coordinate the technical activities of personnel in a specific segment of the Clinical Laboratories to ensure effective technical operation of the unit by established practices; perform specialized procedures requiring advanced skill and theoretical knowledge.
Develop and implement quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment, and compliance with federal regulations; prepare and maintain related records.
Conduct proficiency evaluations of laboratory operations through preparation and distribution of unknown specimens or samples and evaluating the accuracy of solicited results.
Assist in the development and implementation of testing methods, techniques, and procedures for laboratory application; set up and evaluate new laboratory equipment and make recommendations accordingly; standardize laboratory solutions and develop reagents used in diagnostic work.
Provide technical guidance and instruction to personnel in routine and advanced laboratory techniques; conduct formal training programs and workshops for medical technology students, faculty, staff, and other interested personnel.
Assist in planning and scheduling work for personnel ensuring proper distribution of assignments and adequate staffing, space, and facilities for subsequent performance of duties.
Prepare reports and analyses setting forth progress, adverse trends, and appropriate recommendations or conclusions.
Assist in the development and implementation of a comprehensive marketing plan that achieves laboratory budget volumes.
Monitor testing to ensure that acceptable levels of analytic performance are maintained.
Check personnel to assure competence prior to test reporting.
Ensure all aspects of Proficiency testing are properly followed, reviewed, and remedial actions are taken and documented following failures.
Ensure Quality assurance and Quality Control programs are established, maintained, and are effective in identifying problems.
Ensure Procedure manuals are available and have been reviewed annually by director, manager, supervisor, or analytical specialist.
Assure remedial action is taken and documented whenever test systems deviate from established performance specifications.
Ensure that patient testing results are not reported until corrective action has been taken and the test system is functioning properly.
Participate in the annual evaluation, competency testing, and documentation for all testing personnel.
Receive, review, and prepare technical reports reflecting the volume of work, procedures utilized, and test results; coordinate the preparation of reports and analyses setting forth progress, adverse trends, and appropriate corrective action.
Assist in the annual validation of the Electronic Laboratory Manual.