Medical Lab Development Specialist

Description

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Summary:
The purpose of the medical laboratory development specialist positions in the McLendon Clinical Laboratories is, in collaboration with the assistant administrative directors and laboratory directors, to develop laboratory developed tests (LDT's) and advanced diagnostic laboratory testing (ADLT) in highly specialized laboratories. These tests have specific requirements for development and are heavily regulated by the FDA and CMS. These tests typically are performed in laboratories utilizing molecular diagnostic testing or specialized chromatographic methodologies and analytical software applications. The medical laboratory development specialist also will validate high complexity tests that may be FDA approved but require clinical correlations with existing methodologies or clinical diagnoses.

Responsibilities:
1. Work collaboratively in teams as well as independently to complete the daily workload in an efficient manner insuring that all turn-around -times are met. Demonstrate professional and courteous communication with employees, patients and visitors at all times according to the behaviors and scripting provided.
2. Test Development- Works closely with the faculty in the specific laboratory discipline to design test development and validation protocols. Researches literature and contacts appropriate resources to obtain information needed for development. Coordinates schedule to accommodate validation and clinical testing while meeting deadlines for development. Works with manufacturer to coordinate instrumentation modifications for testing. Coordinates tasks with other laboratory staff who may be involved in acquiring specimens, performing parallel testing, or assisting with development. Prepares protocols for new tests consistent with regulatory requirements. Prepares validation summaries for test validations. Troubleshoots problems occurring with development and makes recommendations on modifications to development protocols. Coordinates transition of development testing to clinical testing with laboratory directors and supervisors. Meets with clinicians, researchers, School of Medicine faculty formally and informally to discuss validation progress or to conduct educational sessions on methods. Develops new tests in compliance with regulatory guidelines.
3. The medical laboratory development specialist may perform moderate and high complexity testing independently if they meet CLIA requirements for testing. The medical laboratory development specialist can serve as a CLIA defined general supervisor in a high complexity laboratory upon graduation from a bachelor program or as a CLIA defined technical supervisor after obtaining four years of experience in the testing area. The medical laboratory specialist may serve as a CAP defined technical consultant in performing moderate complexity competency if the medical laboratory development specialists education and experience meet CAP consultant criteria.

Other information:
Education Requirements:
* Bachelor's degree in Medical Technology (Clinical Laboratory Science) or in a biological science
Licensure/Certification Requirements:
* No licensure or certification required.
Professional Experience Requirements:
* Three years of experience in a research laboratory with techniques relevant to the specialty area.
Knowledge/Skills/and Abilities Requirements:
* Nucleic acid (DNA and RNA) preparation and analysis, real-time PCR, sequencing, Computer skills with experience in data processing and analysis

Legal Employer: STATE

Entity: UNC Medical Center

Organization Unit: UNCH Molecular And Cytogenetics

Work Type: Full Time

Standard Hours Per Week: 40.00

Salary Range: $30.73 - $44.18 per hour (Hiring Range)

Pay offers are determined by experience and internal equity

Work Assignment Type: Onsite

Work Schedule: Day Job

Location of Job: US:NC:Chapel Hill

Exempt From Overtime: Exempt: No

This is a State position employed by UNC Health Care System with UNC Health benefits. If, however, you are presently an employee of another North Carolina agency and currently participate in TSERS or the ORP, you will be eligible to continue participating in those plans at UNC Health.

Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email applicant.accommodations@unchealth.unc.edu if you need a reasonable accommodation to search and/or to apply for a career opportunity.