The Center for Immunization Research is looking for a highly motivated, energetic individual with strong focus and attention to detail to work under the direction of the Principal Investigator 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
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
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 (Required)
High School Diploma/GED.
Two (2) years of related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. 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. *
Phlebotomy (required): Proficient with adult phlebotomy and maintenance required.
Preferred fluency in Spanish.
Medical Laboratory Technology Certification preferred.
Special Knowledge, Skills, and Abilities
Requires the ability to flex schedule at the supervisor’s request to work some evenings, nights or weekends as required by study needs, however most work will be accomplished during normal clinic hours, 8:30 am to 5:00 pm.
Will require travel to the inpatient unit on the Bayview campus.
Must be comfortable using Microsoft office software such as Word, Excel and Outlook.
Familiarity with databases (FreezerPro preferable), accurate data entry, and report generation.
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.
May require travel to outlying satellite sites.
Duties may require standing, walking, or sitting for an extended period of time.
Requires dexterity to manipulate objects, such as pipetting and other laboratory duties.
Classified Title: Research Program Assistant II Working Title: Research Program Assistant II Role/Level/Range: ACRO40/E/02/CC Starting Salary Range: $14.14 - $19.44/ commensurate with experience Employee group: Full Time Schedule: Monday - Friday, 8:00a-4:30p / 40 hrs per week/ May occasionally work weekends or evenings. Exempt Status: Non-Exempt Location: 05-MD:School of Public Health Department name: 10001144-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 firstname.lastname@example.org. 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.
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