Classified Title: Sr. Research Specialist Working Title: Sr. Research Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $44,749 - $61,610 Employee group: Full Time Schedule: M-F 8:30-5 Exempt Status: Exempt Location: 4940 Eastern Avenue Mason F Lord Center Department name: 10002806-SOM DOM Clinical Pharmacology Personnel area: School of Medicine
This position is responsible for the management, preparation, high-throughput testing and data analysis within the Clinical Pharmacology Analytical Laboratory. This position specializes in compartmentalized and localized pharmacokinetics of anti-infectives using liquid chromatographic-tandem mass spectrometric platforms, including the Waters Acquity LC systems, and the SCIEX API 4000, 5000, 5500 and 6500 mass analyzers. Further, this position includes familiarity with the handling and bioanalytical management of human specimens, particularly plasma, tissue, and luminal fluids. This position is responsible for the triaging and testing of all pharmacokinetic specimens that come into the laboratory, and this individual will perform high-throughput LC-MS/MS techniques on the aforementioned instrumentation. This position is also responsible for generating maintaining the proper documentation and analysis of large datasets. Further, this position will also participate in the development and validation of new LC-MS/MS methods for small molecule quantification. This position is responsible for the training of junior and new members of the laboratory in the preparation and testing of high volumes of specimens, as well as the proper documentation, management and analysis of large datasets via LIMS systems. Finally, the position will work with Director of the Clinical Pharmacology Analytical Laboratory and other investigators within the Division to execute scientific experiments.
Duties & Responsibilities
Manage the CPAL QA/QC Analytical Runs, Data Reporting, and QC reporting binders as part of the CPAL Quality Management Plan (QMP).
Work with faculty to participate in the validation and documentation of new assay methods for small molecule analysis according to CPQA and FDA Bioanalytical Guideline standards.
Spearhead the preparation, writing, implementation, revision, and review of Assay Validation Reports (AVR) and Standard Operating Procedures (SOP) developed in the laboratory.
Draft and contribute to articles that are submitted to peer-reviewed journals.
Participate as an active member of the NIH Network Clinical Pharmacology Quality Assurance Program to provide quality assurance/analytical support, analyze and review subject data for the NIH network studies.
Communicate with others in the CPAL and the division to express ideas, make suggestions, seek help as necessary, and to work as part of a team
Assist the Laboratory Director and Manager in the daily administration of lab functions.
Interpret and analyze data for large sample sets for network and non-network studies.
Perform the quantitative analysis, principally by LC-MS/MS, of drug/metabolite content in clinical specimens according to established Standard Operating Procedures (SOPs).
Enter network study data into the Laboratory Data Management System (LDMS) and report to the appropriate groups.
Participate in general laboratory duties, including the general upkeep of laboratory (centrifuges, pipettes, etc.) and storage (freezers, refrigerators, etc.) equipment.
Perform daily assessment and troubleshooting of LC-MS/MS and other analytical instruments and equipment.
Use liquid chromatographic and mass spectrometric methods for the quantitative analyses of drug concentrations in clinical specimens.
Maintain quality controls for procedures and function checks on equipment
Assist the Associate Director of CPAL in the evaluation of new techniques and protocols.
Teaching and Training:
Responsible for teaching laboratory methods to student, postdoctoral fellows and laboratory technicians.
PK Sample Manifest Generation
Operation of Waters UPLC Systems, including performance of leak tests, column checks, etc.
Operation of SCIEX API 4000, 5000, 5500 and 6500 mass analyzers
Analysis and review of data and data entry into the lab's LIMS
Customer Service and Teamwork Expectations:
Is courteous and pleasant in person and on the telephone with coworkers, patients, visitors, and supervisors. Utilizes proper telephone etiquette.
Serves as a representative of Division of Clinical Pharmacology outside the confines of the Division's lab and office space.
Functions as a team player and works to maintain harmonious working relationships with coworkers, peers and supervisors.
Recognizes where coworkers need assistance and takes initiative to help.
Scope of Responsibility:
Knows the formal and informal divisional goals, standards, policies and procedures that may include some familiarity of other departments within the school/division.
Is sensitive to the interrelationship of both people and functions within the department.
Knows the role of the position and its potential impact on the working unit.
Carry out duties and responsibilities with limited supervision.
Exercise professional judgment and assume responsibility for own decisions, actions, results, and consequences.
When making decisions will consider the resources available and current priorities.
Supervise, train, and support laboratory technicians, research specialists, and students in performing assays and quality assurance on their data.
Upon request provide input on technical performances and competencies during annual reviews.
Responsible for own work, maintenance of laboratory areas, and laboratory cleanliness.
Must be able to exchange complex and detailed information in an appropriate manner requiring strong oral and written communication.
Must be willing to seek guidance in a timely manner.
Regular interaction with the Division Director, CPAL Director, DDU Director, and other Faculty members who are affiliated with CPAL, and all other lab personnel
HIPPA, Conflict of Interest, Lab Safety Courses as indicated by Johns Hopkins University School of Medicine/Johns Hopkins Medical Institutions.
Bachelor's degree in biology, chemistry or related field. 4 years experience 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: 30 undergraduate degree credits (semester hours) or 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.
Special knowledge, skills, and abilities
Specialized molecular apparatus software
Large database management
LIMS system workflows
Requires experience working with liquid chromatographic-tandem mass spectrometric methods, particularly SCIEX API 4000, 5000, 5500 or 6500 mass analyzers, as well as familiarity with Waters Acquity LC systems.
Demonstrates ability for self-direction and initiation, as well as ability to work independently and as part of a team, to address problems/tasks.
Must be organized and able to appropriately prioritize responsibilities in a fast-paced environment.
Work produced is subject to precise measures of quantity and quality
Work environment may include areas of unpleasant extremes of cold or heat
Biohazardous conditions such as the risk of radiation exposure, fumes or airborne particles, and/or toxic or caustic chemicals may be present in this work environment which mandate attention to safety considerations
Near vision to see objects clearly within 20 inches
Sharp focus to adjust vision when doing close work that changes in distance from eyes
Full spectrum vision to identify and distinguish color
Handling by seizing, holding, grasping, turning or otherwise working with the hand or hands, but without finger dexterity
Sitting in a normal seated position for extended periods of time.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
Communication skills using the spoken word.
Occasionally lifting, carrying objects weighing 10lbs. or less.
Occasionally pushing, pulling objects weighing 30lbs. or less.
Ability to move about.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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