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Johns Hopkins University Research Program Assistant II in Baltimore, Maryland

The Center for Immunization Research is looking for a highly-motivated, energetic individual with strong focus and attention to detail to work as a Research Program Assistant II. This individual will work under the direction of the Principal Investigators and direct supervision of the Research Leadership to carry out essential functions of the CIR. The Research Program Assistant II will work closely with the clinical research staff in the conduct of clinical trials for adult vaccines, therapeutics, and controlled human infections. This individual will support both clinical and laboratory research operations in compliance with study protocol, standard laboratory operating procedures, and regulatory and JHU standards. The Ideal candidate will have a mix of clinical and laboratory experience. A good fit for a Med Tech professional (e.g. EMT, CMA, PCT, phlebotomist, vascular access tech) interested in growing into a career as a clinical research professional. This position will afford an opportunity to experience all facets of conduct of early phase clinical trials, including work within FDA regulations and ICH Good Clinical Practice (GCP) guidelines

Specific Duties & Responsibilities:

Clinical Research Operations

  • Assisting study teams with the implementation of inpatient and outpatient research project(s)

  • recruitment, screening, subject education, conducting informed consent, maintaining up to date knowledge of protocol(s) and protocol related SOPs.

  • Working within IRB and GCP guidelines.

  • Attending training sessions for IRB updates, Human subject’s protection, HIPAA, DOT/IATA, CPR, Bloodborne Pathogens and renewals as required by sponsor or university, and others as assigned.

  • Accurate completion of source documents

  • Data entry and report generation from computer programs such as FreezerPro (specimen tracking database) and NIH database, REDCap and Recruitment databases

  • Attending weekly planning meetings, and CIR team meetings

  • Willing to learn how to obtain and record vital signs

  • Assisting and supporting other staff when necessary, and knows when to seek assistance.

  • Assist in maintaining and supplying the CIR clinical research units

  • Perform reasonable job duties, even if not part of the job description, as assigned by supervisor or Principal Investigator.

  • Complete annual CPR and other regulatory, clinical, and laboratory training and certifications as requested.

Clinical Research Laboratory Operations

  • Research and clinical specimen collection (i.e., volunteer blood, urine, saliva, stool and nasal wash), testing and processing

  • Phlebotomy (required; will train)

  • Complying with universal safety precautions to protect self and co-workers from biohazardous materials, including blood-borne pathogens

  • Perform and document clinical laboratory testing allowed by CLIA

  • Specimen Preparation – printing specimen labels, labeling specimens and aliquot tubes, printing requisitions, centrifuging samples

  • Specimen Processing – Completing specimen tracking sheets, Urinalysis, Serum hCG, flash freezing, aliquoting, packaging and sample transport to processing and storage locations.

  • Ship specimens according to DOT/IATA standards

  • Coordinate manufacturer recommended calibration/maintenance of centrifuges, microscopes, pipettes, specimen freezers and refrigerators

  • Equipment maintenance –Clean centrifuges, drain and clean water bath, wipe microscope lenses, de-ice Freezers, check and log freezer/refrigerator temps, check emergency equipment

  • Assist in the creation/revision of clinical laboratory procedures according to GCP/GLP standards

  • Complying with laboratory QA/QC protocols and procedures and lab safety protocols

  • Create specimen collection flow sheet for new study protocols

  • Maintain all clinical laboratory documents including but not limited to SOPs, MSDS and equipment maintenance logs

  • Participating in freezer inventory

  • Operate laboratory equipment

Minimum Qualifications (Mandatory):

  • High School Diploma/GED

  • Two years related experience

  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula

Preferred Qualifications:

  • Preferred fluency in Spanish

  • Medical Laboratory Technology Certification preferred

  • Proficient with adult phlebotomy or willingness to learn and maintenance

Special Knowledge, Skills & Abilities:

  • Must be comfortable using Microsoft office software such as Word, Excel and Outlook

  • Familiarity with databases (FreezerPro preferable), accurate data entry, and report generation

Technical Qualifications/Specialized Certifications:

  • Any specific physical requirements for the job: Occasionally lifting, carrying, pushing, and/or pulling objects weighing up to 50 lbs., such as specimens packed in dry ice

  • Will require foot travel within the JHMI campus, particularly between the clinic on Broadway Street and the laboratory on Wolfe Street

  • Will require travel to the inpatient unit on the Bayview campus

  • May require travel to outlying satellite sites

  • Duties may require standing, walking, or sitting for an extended periods of time

  • Requires dexterity to manipulate objects, such as pipetting and other laboratory duties

Classified Title: Research Program Assistant II

Role/Level/Range: ACRO40/E/02/CC

Starting Salary Range: $15.00 - $20.00/hr (commensurate with experience)

Employee group: Full Time

Schedule: Mon - Fri. 8.00 hrs.

Exempt Status: Non-Exempt

Location: School of Public Health

Department name: Ctr for Immnztn Rsch Vaccine Scis CIR

Personnel area: School of Public Health

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.

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 or because the individual is pregnant or attempting to become pregnant. 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 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.

Equal Opportunity Employer

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Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.