The Bronx Prevention Center, part of ICAP at Columbia University, is a Clinical Research Site (CRS) within the NIH-funded AIDS Clinical Trials Unit at Columbia University. Located in a clinical office on East 158th Street in the Bronx, the site has over ten years of experience conducting phase 1 and 2 and observational HIV prevention clinical trials.
The Study Assistant will assist with grant-funded HIV prevention clinical research studies, including a study of the safety and efficacy of a monoclonal antibody in preventing HIV infections in men who have sex with men and transgender individuals.
Under the direct supervision of the Site Coordinator, the Study Assistant will serve as a courier between Bronx Lebanon Hospital Center Pharmacy and the study site, help with the recruitment and retention of participants, and conduct other aspects of HIV Prevention clinical trials as needed.
This position is grant funded.
LOCATION: East 158th Street, Bronx, NY
Major Accountabilities:
- Serve as a courier up to several times a day between the Bronx Prevention Center clinical research site at 390 East 158th Street, Bronx, NY and the Bronx-Lebanon Hospital Center Research Pharmacy at 1650 Grand Concourse, Bronx, NY.
- Prescreen the potential study participants for study eligibility according to study protocol, and schedule screening appointments with those who are found to be eligible.
- Answer phone calls and schedule participant appointments.
- Assist with follow-up visits and implement retention plan.
- Assist in preparing and maintaining up-to-date study participant files.
- Assist the Data Manager to check log books, data collection forms, and documentation to assure compliance with Standard Operating Procedures (SOPs).
- Complete relevant case report forms.
- Maintain confidentiality of study participants and adhere to principles of Good Clinical Laboratory Practice (GCLP), Human Subject Protection (HSP), and International Air Transport Association (IATA) regulations.
- Establish and maintain positive relationships and interact professionally, courteously, and appropriately with potential participants, participants, visitors and other employees; furthering a positive public perception of the research site and its employees.
- Assist with designated aspects of the study including ensuring site compliance with study protocols, all relevant procedures, policies and regulations. Understand and adhere to study protocols, and other appropriate regulations, procedures and policies.
- Perform other related duties as assigned.
Travel Requirements:
- Travel by bus or taxi at employer’s expense, up to several times a day is required. This will be, between the Bronx Prevention Center clinical research site at 390 East 158th Street, Bronx, NY and the Bronx-Lebanon Hospital Center Research Pharmacy at 1650 Grand Concourse, Bronx, NY to retrieve study product and deliver documents
- Occasional domestic travel to research training and meetings (1-2 times per year, approximately 3 days each) may be required
Education
- High School graduate or equivalent with at least six months related experience.
Experience, Skills & Minimum Required Qualifications
- 1+ year of related experience in clinical research
- Excellent oral, written, organizational and interpersonal skills
- Working knowledge of computers and Microsoft Office Suite
Experience, Skills & Preferred Required Qualifications
- Prior HIV prevention research or clinical research program experience
- Experience working with populations at elevated risk of HIV acquisition, such as men who have sex with men and transgender individuals
- Certifications in Good Clinical Laboratory Practice (GCLP), Human Subjects Protection (HSP), and International Air Transportation Association (IATA) preferred
- Spanish language skills
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