Oversees a variety of complex experimental tests and leads in development of new molecular assays and techniques. Requires subject matter expertise/knowledge to execute and analyze results. Performs clinical assay development. Multiple tests will be developed in parallel. Independence in reviewing, understanding and applying literature in consultation with pathologists is required. Coordinates with other staff doing developmental work and collaborates with technologists who will be performing the test clinically once development has been completed.
Specific Duties & Responsibilities
Using comprehensive scientific knowledge, maintains both research and clinical diagnostic test environment.
Performs a variety of complex technical procedures on different specimens, including but not limited to: blood, CSF, respiratory,or formalin-fixed paraffin embedded specimens in the assigned laboratory.
Maintains divisional compliance with all regulatory standards and adheres to all established QA/QC procedures. Documents results under quality assurance guidelines and provides recommendations to technical staff, ensuring reproducibility of results.
Follows standard operating procedures for preparing samples developed for molecular assays in support of patient care and research.
Troubleshoots implementation of new venues or protocols to the lab SOP’s. Develops new quality standards for molecular assays.
Works closely with the Medical Directors to understand their scientific questions/aims, and offer support, implementation, and analysis of any type of molecular assay to reach their goals.
Performs literature search and review, and orders necessary supplies, in preparation for development.
Ensures that data is accurately maintained and organized. Records timelines, status reports, and logs. Maintains laboratory notebooks.
Writes SOPs and validation summaries for completed development projects, and assists in manuscript writing.
Works with laboratory support staff and assists in the training of technical personnel.
Strictly complies with patient care and confidentiality policies, HIPAA regulations.
Bachelors degree, in biology, chemistry, or related field. 5 years experience in a comparable laboratory performing relevant techniques. Master’s degree with related graduate research may substitute for some experience to the extent permitted by the JHU equivalency formula.
* JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job. *
Masters degree and knowledge of clinical and research testing preferred.
Special Knowledge, Skills, and Abilities
Work produced is subject to precise measure of quantity and quality; Attention to detail is critical to the successful performance of this job as it directly affects patient diagnoses or research outcomes.
Computer, Copier, Telephone, Fax.
Experience and understanding in laboratory instrumentation and equipment including: assay methods, maintenance requirements and general operational trouble shooting.
Physical requirements for the job:
While performing the duties of this job, the employee is regularly required to sit, talk, see and hear. May sit or stand for prolonged periods and occasionally required to walk. The employee is frequently required to use hands to finger, touch, feel, and type. May reach with hands and arms; stoop, kneel, or crouch. Prolonged vision requirements including viewing computer screen, paper reports/documents, charts and results.
Visual acuity is required to distinguish fine gradation of color or structure and closely examine specimens microscopically. Must possess manual dexterity sufficient to work with small instruments and delicate equipment.
Clinical laboratory environment - Exposure to toxins and infectious agents exist, but potential for personal injury or harm is minimized if established safety and health precautions are followed. Working in laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment.
May transport equipment and supplies usually less than 40 pounds from one area to another. May be required to lift and/or move up to 50 pounds with proper training, or precautions/lifting aides.
In some areas work space is confined; therefore mobility may be difficult.
Staff may be required to complete annual competency review, and must insure compliance with Hospital Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices.
Must be detail oriented, organized, and accurate.
Many department laboratories operate 24/7 with schedules on day, evening, or night shift. Rotating schedules which may include weekend work and holiday assignment. Overtime possible when authorized/needed to meet business and patient needs.
The above statements are intended to describe the general nature and level of work being performed. They are not to be construed as an exhaustive list of skills, efforts, duties, responsibilities, knowledge, or abilities required of the position.
Classified Title: Clinical Laboratory Specialist Working Title: Clinical Laboratory Specialist Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495 - $72,210; Commensurate with Experience Employee group: Full Time Schedule: Monday-Friday, 8:30a-5:00p, up to 37.5 hrs/ week Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003057-SOM Pat Pathology Medical Microbiology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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