The Pathology Department is seeking an International Lab QA/QC Coordinator who will be a Proficient medical technologist or equivalent with emphasis CLIA/CAP-related laboratory testing, coordination of sample receipt, shipping, and storage with an understanding of laboratory information systems. This individual will coordinate testing, investigation reports, shipping, and storage activities with the HPTN Laboratory Center (LC) Deputy Director and other Domestic QA/QC Coordinators, as well as HPTN LC International QA/QC Coordinators and HPTN LC Supervisors/Managers. This role works independently and manages complex projects including maintaining CLIA/CAP licensure and sample and data management.
Specific Duties & Responsibilities:
Using knowledge of current accrediting and regulatory requirements ensures laboratory programs are in compliance with such requirements.
Sharing knowledge gained from professional experience in HIV, Chemistry, Hematology, Microbiology, Serology, and/or Virology clinical laboratory sections to assure international laboratory compliance with current Good Clinical Laboratory Practice (GCLP) and other regulations and/or guidelines as defined by the HPTN.
Review and monitor the technical quality of all HPTN protocol related test results. Monitor proficiency test results and help maintain the proficiency testing database.
HPTN Protocol team member.
Implement and monitor appropriate QA/QC pre-analytical functions (specimen labeling, processing) analytical functions (testing), and post analytical functions (test reporting, specimen storage/shipping) to assure validity of results and appropriate HPTN protocol related chain of custody of specimens.
Ensure that protocol related tests have been validated and the appropriate validations are readily available. This includes reference range validations.
Join HPTN protocol related team calls.
Review site inventory related to HPTN protocol.
Assist with laboratory data management on new studies involved in portal uploads.
Provide LDMS refresher training during protocol team trainings.
Provide Study Monitoring reports and Study Operations reports.
Assist with training of technologists in specific test procedures or QA procedures to be used in protocol testing.
Compile data into statistical summary reports using Microsoft Excel or database program and provide status reports to the laboratory, NIH, and other study sponsors.
Coordinator will assist with the coordination and monitoring of proficiency testing activities at study sites and LC.
May be required to develop and review SOPs, reports, scientific protocols, and other papers; and provide status updates and/or recommendations Review and update laboratory SOPs as appropriate.
Provide expertise in troubleshooting general laboratory problems or specific assay problems
Provide Excel and Access Database maintenance for use in Data analysis related to LC generated laboratory data as well as for use in instrument programming.
Update spreadsheets as needed for protocol sample listings
Work with the SDMC biostatisticians to coordinate the comparison of the LC QA generated laboratory results with the site results.
Resolve any mis-matched results with the site. Coordinator must also be able to identify QA system failures, recommend solutions, and provide assistance to international laboratories when corrective actions are indicated.
Perform routine and specialized testing. Assure that EQA testing is handled in the appropriate manner and follows the local QA documentation. May be required to train other lab personnel.
Importation of protocol related samples utilizing the LDMS system.
Performs, documents and writes up validation work for new diagnostic point-of-care tests and new HIV assays.
May be involved in preparation of abstracts, meeting presentations and manuscripts. Reviewing and updating laboratory SOPs as needed; writing new SOPs as appropriate.
Travel to domestic and international sites, as needed.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Medical Technology 4 years related clinical laboratory experience.
Must have working knowledge of CAP and CLIA regulations and NCCLS procedure formats applicable in a clinical lab.
Experience in hematology, chemistry, and HIV antibody and RNA assays.
Advanced knowledge of good laboratory practices required.
Special Knowledge, Skills & Abilities:
Training in HIV and STD laboratory diagnostic methods.
Design and conduct of clinical trials.
Strong working knowledge of computers, skilled in Microsoft Office Word, Excel, file organization, and internet research.
Working knowledge of GCLP, CAP, CLIA regulations and CLSI procedure formats applicable to an accredited clinical lab.
Individual must to work independently, under minimal supervision with strong decision-making skills and good judgment.
Strong written and verbal communication, interpersonal, and training skills.
ASCP (or equivalent) Medical Technologist certification preferred.
While performing the duties of this job, the employee may remain in a stationary position up to 75% of the time when at the office. May require travel nationally and internationally (developing countries), where working conditions will vary significantly including traversing on uneven terrain, working in extreme weather conditions, and taking appropriate caution for personal safety may be required.
The employee is required to operate computer keyboard, laboratory instruments, and small laboratory tools such as pipettes, cutting instruments, glass tubes, dishes, and/or slides.
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 (including via a microscope).
While this position is primarily in an office setting, there are times when you will work in a 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. Must refer to and are expected to comply with procedure manuals, follow proper laboratory protocols and safety policy/procedures, and be familiar with material data safety sheets in assigned work areas.
Able to read and understand all Health, Safety and Environment (HSE) guidelines applicable to assigned work area. Working in laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment. Research areas may include animal, human, human products, DNA, and radiation protocols.
Use of personal protective equipment may be advised or required.
May transport equipment and supplies usually less than 40 pounds from one area to another including laboratory supplies or luggage. 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 limited.
Staff may be required to complete annual competency review, and must insure compliance with Johns Hopkins Policy, local laboratory, health safety and environment policies and procedures and all applicable privacy & confidentiality laws/practices.
Classified Title: International Lab QA/QC Coordinator Role/Level/Range: ACRP/04/MD Starting Salary Range: $53,020 - $72,935 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:00am - 4:30pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Pat HIV Clinical and Research 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 following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
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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