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Support for Antibody Mediated Prevention (AMP) Study(NYC-2)

June 1, Length: 5-6 Months

Location: New York, NY

The Harlem Prevention Center is participating in HVTN 704/HPTN 085, the AMP study, to test the antibody VRC01 against the HIV virus. The VRC01 antibody was developed by the Vaccine Research Center at the U.S. National Institutes of Health (NIH). The study is sponsored by the HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN), and funded by the NIH.

HVTN 704/HPTN 085 is a phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection. The study will enroll 3900 HIV-1–uninfected volunteers aged 18 to 50 years, including 2400 men who have sex with men (MSM) or with transgender persons (TG), and TG who have sex with men or TG in North and South America as well as 1500 women at risk of HIV-1 infection in sub-Saharan Africa. HVTN 703/HPTN 081 is a multicenter, randomized, controlled, double blind study. Participants will be randomly assigned to receive either one of two dosing concentrations of the VRC01 or a placebo control. Participants will be followed for 21 months of scheduled clinic visits; total estimated study duration is 57 months. Data are collected from participants by research counselors and study clinicians at study visits which occur monthly for a total of 26 scheduled visits over a period of 21 months.

Scope of Work
Under the supervision of the Site Coordinator, the student will contribute to study implementation and data management, including quality control of study data and quality assurance activities. The student will work closely with the HVTN704/HPTN 085 team to support data management activities, including but not limited to the following:

  • Conduct data monitoring and quality assurance on data collected for the study, including:
    • Review study case report forms, surveys, and source documents for completeness and issue queries to research staff
    • Review eligibility criteria of screened study participants for enrollment, including review of eligibility case report forms, source documents and informed consent forms
    • Assist with submission of study forms to the statistical and data management center
    • Assist with prompt review of all data queries and their immediate resolution
    • Identify problem areas with data collection, report findings to the project’s leadership, and develop appropriate corrective measures with input from the team
    • Help the study team prepare IRB submissions and updates as needed
  • Assist in summarizing data and preparation of presentations for scientific meetings
  • Other duties as assigned by the Site Coordinator and Investigators

Qualifications

Minimum:

  • Excellent oral/written communication, interpersonal, organizational, and computer skills
  • Flexible, open-minded, and able to easily adapt to new challenges

Preferred
  • Experience working with research and data management is highly desired