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 Adult Nurse Practitioner 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 Senior Site Clinician, the Adult Nurse Practitioner will screen prospective participants for study eligibility and obtain informed consent; obtain medical histories and conduct physical examinations of all screened and enrolled study participants; prescribe study medications; administer infusion therapy; assess symptoms and medication side- effects; review laboratory results and assess reported adverse events related to study participation in HIV prevention clinical trials; and conduct other aspects of HIV prevention clinical trials as needed. The Adult Nurse Practitioner will be responsible for the collection, documentation and completion of case report forms as per study protocols and study-specific procedures.
* Obtain medical histories, conduct physical examinations and assess symptoms of all screened and enrolled study participants in accordance with protocol requirements.
* Administer study product and perform other protocol-defined procedures including but not limited to intravenous infusions, vital signs, rapid HIV testing and phlebotomy.
* Complete study-related case report forms and source documentation per protocol.
* Review all screening laboratory results to determine participant study eligibility.
* Assess and manage reported symptoms and other adverse events.
* Write and sign study specific prescription and corresponding New York State prescription for study drugs.
* Participate in quality assurance activities in collaboration with the site’s Data Manager and the network’s Statistical and Data Management Center.
* Manage and oversee some clinical study staff on day-to-day activities of study implementation and administration. This includes clinical procedures per protocol and quality control and continuous quality improvement.
* Perform the consent process and obtain signed informed consent prior to initiating any protocol-defined procedures.
* Maintain accurate, comprehensive study records and source documentation.
* Maintain confidentiality of study participants and adhere to principles of Human Subjects Protection (HSP) and Good Clinical Laboratory Practice (GCLP).
* 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.