CDC’s Maryland Emerging Infections Program/Active Bacterial Core surveillance (ABCs) based at the Johns Hopkins School of Public Health (JHSPH) is about to initiate a complex multi-faceted clinical study, the Group B Streptococcus (GBS) Dried Blood Study, to establish GBS immunologic endpoints reasonably likely to predict clinical benefit against invasive GBS disease among young infants. The individual in this position will lead the implementation of and oversee the day-to-day activities of this three-year study. Study implementation involves interaction with and data collection and synthesis from study partners at the Johns Hopkins Hospital, the Maryland Department of Health, the University of Pittsburgh, and the Centers for Disease Control and Prevention.
Specific Duties & Responsibilities:
Participate in study design.
Develop the study SOPs for each of the participating partners.
Oversee the day-to-day activities of the study and study staff.
Train study staff on implementation of study procedures.
Prepare IRB submissions.
Recommend and prepare revisions to study protocol.
Develop and maintain study consent forms.
Participate in developing and adhering to the study budget.
Assist with preparation and submission of study reports.
Utilize standard statistical techniques to run standard statistics. Ensure accuracy of data entry and conduct quality control activities to assure adherence to the study protocol.
Conduct literature searches to provide background information. Abstract and index information based on knowledge of subject matter.
Oversee study enrollment.
Oversee specimen shipping.
Routinely liaison with CDC and other study partners for study progress.
Bachelor's degree in related discipline.
Three (3) years 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. *
Bachelor’s degree and a minimum of 3 years’ experience conducting clinical studies; experience using REDCap and ACCESS databases, knowledge of medical terminology and laboratory testing procedures; able to coordinate multiple ongoing aspects of the study; able to work independently as well as cooperatively to ensure accurate and timely completion of study activities. Able to effectively engage and communicate with study partners for successful implementation of study activities. Must be detailed and accurate in data collection and reporting.
Advanced degree in a related discipline, laboratory experience, experience working in OBGYN and/or clinical research setting, ability to commit at least three years to working on the study. Experience in preparing IRB submissions and study reports.
Special Knowledge, Skills, and Abilities
Experience managing clinical trials; conducting chart reviews and using EPIC. Knowledge of biospecimen collection and shipping procedures.
Will obtain HIPPA and CITI certification; will obtain clinical specimen shipping certification.
Ability to travel to clinical sites within the Baltimore metro area.
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coodinator Role/Level/Range: ACRP/03/MB Starting Hourly Pay Rate Range: Employee group: Full Time Schedule: 8:30am - 5:00pm, M-F Exempt Status: Exempt Location: 31-MD:JH at 111 Market Place Department name: 10001140-Global Disease Epidemiology and Control 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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