The Pathology Department is seeking a Clinical Laboratory Specialist who will oversee 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 both research and clinical assay development.
Independence in performing annotation and preparing reports for clinical NGS assays. 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. Performs annotation and prepares reports for clinical NGS assays.
Specific Duties & Responsibilities:
Using comprehensive scientific knowledge, maintains both research and clinical diagnostic test environment.
Complete QC and clinical data analysis.
Replicate the multi-step processes described in SOPs and demonstrated by competent lab members.
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 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 assays as needed.
Works closely with Laboratory Manager and Medical Directors to understand their scientific questions/aims, and offer support, implementation, and analysis of assays to reach their goals.
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.
Work as part of a team in a coordinated fashion and support the overall mission of the Department – to provide state of the art clinical care in a safe, efficacious and accurate manner. Balance performing several different tasks through the workday.
Performs miscellaneous related duties as assigned.
Minimum Qualifications (Mandatory):
Bachelor's Degree, in Biology, or related field.
Five years in a comparable laboratory performing relevant techniques.
Master's Degree, with related graduate research, may substitute for experience to the extent permitted by the JHU equivalency formula.*
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. 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.
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Master's Degree and Informatics experience, especially with NGS, preferred.
Will consider Bachelor's Degree with extensive molecular biology experience, or Ph.D. Degrees.
Special Knowledge, Skills & Abilities:
Extensive knowledge of clinical and research testing. 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.
Complex nature of this position requires an individual with subject matter expertise and ability to work independently.
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.
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.
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.
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 Role/Level/Range: ACRP/04/MD Starting Salary Range: $53,020 - $72,930 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am-5:00pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Pat Molecular Diagnostics Lab 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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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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