Research Specialist

General Summary

The Clinical Pharmacology Analytical Laboratory (CPAL) is a multi-discipline laboratory with focuses on; the development and validation of genetic assays using PCR techniques for clinical implementation; biological sample collection and processing; and the development, validation, and implementation of bioanalytical assays to support clinical trials. This position requires molecular biology experience and focuses on supporting pharmacogenetics (PGx) testing in accordance in a College of American Pathologists (CAP) accredited environment. This position will also involve maintaining standard operating procedures and interpreting laboratory results. Lastly, this position will involve participation in clinical trial studies, including the collection and processing of biological materials for molecular and/or pharmacologic analysis. This position focuses on supporting and maintaining laboratory equipment in the CPAL’s biological processing and molecular genetics areas.

Duties and Responsibilities:

• Follow the practices of the lab, with regards to: maintenance of notebook, nomenclature for labeling datasets, and storage of laboratory documents in the appropriate areas (i.e. shared server folders).
• Be proficient in PCR-based techniques, include development of primers and targeted molecular probes.
• Interpret and analyze data for large sample sets for molecular genetics and PGx studies.
• Be compliant with CAP standards in the performance of PGx testing.
• Assist in the collection of clinical samples at the point of collection.
• Prepare biological samples for biochemical analysis.
• Be capable of exercising independent judgment while participating in the planning of experiments, execution of research protocols, as well as the evaluation and interpretation of the results.
• Provide general laboratory support, including general upkeep of laboratory (centrifuges, pipettes, etc.) and storage (freezers, refrigerators, etc.) equipment.
• Utilize prior experience and comply with biohazard/radiation safety standards through proper handling and storage of hazardous chemical and biological agents, and radiation sources in the laboratory.
• Participate in process improvement initiatives.
• Work with CPAL QA/QC Manager to ensure laboratory activities meet regulatory standards.

Essential Job Functions:

• Experience using universal safety precautions to protect self and co-workers.
• Able to follow and adhere to existing Standard Operating Procedures (SOP).
• Able to adhere to schedules and protocols.
• Able to plan experiments and evaluate/interpret results.
• Assist in drafting or revising SOPs.
• Able to communicate with others in the lab, to seek help, make suggestions and express ideas as necessary.
• Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.Complete annual university biohazard/universal precaution/radiation safety training.
• Monitor equipment performance, and may perform routine maintenance or repairs.
• Adhere to biohazard/radiation safety standards for the proper handling and disposal of potentially hazardous chemical and biological agents and/or radiation sources in the workplace.
• Attend and participate in weekly staff and division meetings, protocol and research related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned.
• Complete and maintain up to date documentation of compliance requirements indicated by the Johns Hopkins University and the Johns Hopkins Hospital, including but not limited to: JHM Research Compliance, HIPAA, Bloodborne Pathogens, Biohazard Precaution, and Radiation Safety.
• Properly catalogue and transmit data using electronic software programs, including LDMS and Microsoft Excel.
• Will have knowledge of the policies, procedures and practices necessary to conduct the work described above and an awareness of the role and importance of the position within the CPAL and its potential impact on the working unit

Physical Requirements

• Occasionally lifting, carrying objects weighing 20 lbs. or less.
• Sharp focus to adjust vision when doing close work that changes in distance from eyes.
• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.

Minimum Qualifications

• Bachelor's degree in biology, chemistry or related field required.
• One year of laboratory experience 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 (semester hours) 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.

Preferred Qualifications

•Master's degree in biology, chemistry or related field preferred.

1-year experience with primer design, DNA extraction, PCR-amplification, and other molecular biology techniques.

• Demonstrated organizational and time management skills with a high degree of attention to detail.

• Ability to manage multiple and competing priorities.

General Summary

The Clinical Pharmacology Analytical Laboratory (CPAL) is a multi-discipline laboratory with focuses on; the development and validation of genetic assays using PCR techniques for clinical implementation; biological sample collection and processing; and the development, validation, and implementation of bioanalytical assays to support clinical trials. This position requires molecular biology experience and focuses on supporting pharmacogenetics (PGx) testing in accordance in a College of American Pathologists (CAP) accredited environment. This position will also involve maintaining standard operating procedures and interpreting laboratory results. Lastly, this position will involve participation in clinical trial studies, including the collection and processing of biological materials for molecular and/or pharmacologic analysis. This position focuses on supporting and maintaining laboratory equipment in the CPAL’s biological processing and molecular genetics areas.

Duties and Responsibilities:

• Follow the practices of the lab, with regards to: maintenance of notebook, nomenclature for labeling datasets, and storage of laboratory documents in the appropriate areas (i.e. shared server folders).
• Be proficient in PCR-based techniques, include development of primers and targeted molecular probes.
• Interpret and analyze data for large sample sets for molecular genetics and PGx studies.
• Be compliant with CAP standards in the performance of PGx testing.
• Assist in the collection of clinical samples at the point of collection.
• Prepare biological samples for biochemical analysis.
• Be capable of exercising independent judgment while participating in the planning of experiments, execution of research protocols, as well as the evaluation and interpretation of the results.
• Provide general laboratory support, including general upkeep of laboratory (centrifuges, pipettes, etc.) and storage (freezers, refrigerators, etc.) equipment.
• Utilize prior experience and comply with biohazard/radiation safety standards through proper handling and storage of hazardous chemical and biological agents, and radiation sources in the laboratory.
• Participate in process improvement initiatives.
• Work with CPAL QA/QC Manager to ensure laboratory activities meet regulatory standards.

Essential Job Functions:

• Experience using universal safety precautions to protect self and co-workers.
• Able to follow and adhere to existing Standard Operating Procedures (SOP).
• Able to adhere to schedules and protocols.
• Able to plan experiments and evaluate/interpret results.
• Assist in drafting or revising SOPs.
• Able to communicate with others in the lab, to seek help, make suggestions and express ideas as necessary.
• Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.Complete annual university biohazard/universal precaution/radiation safety training.
• Monitor equipment performance, and may perform routine maintenance or repairs.
• Adhere to biohazard/radiation safety standards for the proper handling and disposal of potentially hazardous chemical and biological agents and/or radiation sources in the workplace.
• Attend and participate in weekly staff and division meetings, protocol and research related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned.
• Complete and maintain up to date documentation of compliance requirements indicated by the Johns Hopkins University and the Johns Hopkins Hospital, including but not limited to: JHM Research Compliance, HIPAA, Bloodborne Pathogens, Biohazard Precaution, and Radiation Safety.
• Properly catalogue and transmit data using electronic software programs, including LDMS and Microsoft Excel.
• Will have knowledge of the policies, procedures and practices necessary to conduct the work described above and an awareness of the role and importance of the position within the CPAL and its potential impact on the working unit

Physical Requirements

• Occasionally lifting, carrying objects weighing 20 lbs. or less.
• Sharp focus to adjust vision when doing close work that changes in distance from eyes.
• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
  

Minimum Qualifications

• Bachelor's degree in biology, chemistry or related field required.
• One year of laboratory experience 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 (semester hours) 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.
  


Preferred Qualifications

•Master's degree in biology, chemistry or related field preferred.

1-year experience with primer design, DNA extraction, PCR-amplification, and other molecular biology techniques.

• Demonstrated organizational and time management skills with a high degree of attention to detail.

• Ability to manage multiple and competing priorities.

Classified Title: Research Specialist
Role/Level/Range: ACRP/03/MA
Starting Salary Range: Commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30-5pm
Exempt Status: Non-Exempt
Location: School of Medicine Campus
Department name: SOM DOM Clinical Pharmacology
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

Accommodation Information

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. 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.

Note: Job Postings are updated daily and remain online until filled.

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm