Supervise, coordinate, and perform a variety of highly complex technical tasks associated with the performance of laboratory tests to obtain data for use in the diagnosis and treatment of disease. Job duties are dependent on the specialty laboratory and may be composed of a combination of the following duties and responsibilities related to the specialization. Tasks are performed according to written procedures and policies with careful monitoring of quality control and quality assurance practices.
Supervise, coordinate, and perform a variety of highly complex technical tasks in a variety of specialized laboratories. Tasks are performed according to written procedures and policies with careful monitoring of quality control and quality assurance practices. Coordinate and participate in specialized laboratory procedures requiring advanced skill and theoretical knowledge. Operate complex or computerized instrumentation. Calibrate, maintain , align, and troubleshoot/repair instrumentation according to standard operating procedures and knowledge and experience. Supervise and ensure the timely processing of patient samples or perform processing as needed based on staffing levels using appropriate identification techniques and written procedures to ensure quality material for testing. Provide advanced problem solving, troubleshooting, interpretation and consultation, verification of specimen quality and test results. Communicate problems/issues to responsible individuals. Oversee the maintenance of inventory. Lead, coordinate, and/or perform in the development and validation of clinical assays to include performance, analysis, and written documentati on of findings. Maintain appropriate documentation of initial and ongoing validations in compliance with internal and external regulatory agencies. Make recommendations for new equipment, set up, evaluate, and operate new equipment required for specific laboratory tests and assume adequate responsibility to maintain operations, including validation of instrumentation, standard operating procedures, and schedule for preventative maintenance. Supervise, coordinate, and participate in lab inspections; work with inspectors. Interpret accrediting agencies' standards or guide lines and translate requirements into departmental operation policies and procedures. Evaluate section readiness and adhere to standards. Implement corrective action as soon as any deficiency is identified. Bring any non-compliance issues to the attention of management. Coordinate, oversee and perform proficiency testing as directed to maintain compliance with regulatory agencies. Develop and oversee quality control and quality assurance procedures and programs to ensure compliance with internal and external regulations. Recognize, respond to, and report issues as needed. Assure remedial action is taken and documented whenever test systems deviate from established performance specifications. Ensure that patient results are not reported until corrective action has been taken and the test system is functioning properly. Ensure all written procedures and policies are current and have been reviewed by supervisor or manager. Collaborate with management team to initiate projects and develop action plans to improve unit performance through a Process Improvement (PI) project. Maintain turnaround time and other key indicators and provide reports to management. Make recommendations for plans to improve unit performance through a process improvement project. Institute, understand, comply , and perform all necessary safety procedures. Maintain compliance with all safety training. Report all safety incidents within 24 hours. May prepare lab meeting agendas. Review staff safety and compliance training to ensure completion. Oversee and coordinate competency assessment of staff. Conduct competency testing of personnel as assigned by management. Comply with competency testing for the laboratory staff. Oversee training of new staff. Ensure documentation of training is complete. Develop and institute laboratory training programs including documentation. Provide technical guidance and instruction to students, interns, residents, staff, and other employees. Plan and schedule work for the group ensuring proper distribution of assignments and adequate staffing, and resources for subsequent performance of duties. Recommend space, equipment, and other resources as needed to meet patient needs. Monitor workflow, assessment of staffing levels and reassignment as needed. Follow up to ensure work is completed. Perform other related duties incidental to the work described herein. Use behaviors that support achievement of balanced scorecard targets and support DUHS (Duke University Health System) values. Ensure cooperation and effective communication amongst staff regarding work flow.
Knowledge, Skills and Abilities
Ability to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities.
Within the clinical laboratories we embrace Duke' s purpose, placing the patient at the center of everything we do. We do this by demonstrating behaviorsthat focus on delivering patient- and family- centered care and embodying the values that promote a positive work culture. We expect every team member to commit to these values and hol d each other accountable in the spirit of mutual respect and belonging. Promotion to this level is dependent upon successful completion of leadership activities within the Clinical Ladder. Requires annual maintenance.
Bachelors of Science/Bachelor of Arts in Chemical, Physical, Biological or Clinical Laboratory Science; or Medical Technology. Generalist certification required for General labs. Generalist/Specialty certification required for specialty labs. 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.
Five years (including one year at Duke) with generalist/specialty certification in a specialty laboratory.
Degrees, Licensures, Certifications
Generalist/Specialty Certification by a nationally recognized board/agency (required). Certification will vary depending on laboratory. Advanced degree (MS or higher) accepted in lieu of certification.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
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