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 18 years of experience conducting phase 1 and 2 and observational HIV prevention clinical trials.
The Study Nurses will assist with grant-funded HIV prevention clinical research studies and grant-funded studies related to Covid-19 prevention and other prevention studies for a four-month period.
Under the direct supervision of the Clinical Coordinator, the Study Nurse will conduct study visits in the field, on the van and on site. The study Nurse will assist with the screening of prospective participants for study eligibility and obtain informed consent; obtain medical histories and conduct physical examinations of all screened and enrolled study participants; complete follow up visits and administer study product
Administer study product, monitor, complete and document the administration of study product per study protocol procedures. (20%)
Obtain medical histories, conduct physical examinations and assess symptoms of all screened and enrolled study participants in accordance with protocol requirements. (20%)
Identify and report to the study clinicians any adverse events that are noticed and/or reported by study participants and assist with collecting study samples. (10%)
Complete study-related case report forms and source documentation per protocol, review all screening laboratory results to determine participant study eligibility and assess and manage reported symptoms and other adverse events. Check source documentation and case report forms for completion and accuracy, and correct data errors when present. (15%)
Perform the consent process and obtain signed informed consent prior to initiating any protocol-defined procedures and completing follow up visits per protocol. (15%)
Maintain confidentiality of study participants and adhere to principles of Human Subjects Protection (HSP) and Good Clinical Laboratory Practice (GCLP). (5%)
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. Assist with preparation for any monitoring visits; address QC queries and respond to QC items on the infusion visits. (5%)
Set up examination rooms and instruments in accordance with protocol needs and proper sterilization techniques. (5%)
Perform other related duties as assigned (5%)
Bachelor's degree or equivalent plus 4 years of related experience
Current NYS RN license
Experience with phlebotomy, intravenous line placement, administering infusions, and familiarity with lab procedures
Current BLS certification
Demonstrated experience organizing and managing disparate work flows to meet organizational schedules and requirements
Excellent oral, written and interpersonal skills
Excellent computer skills and proficiency with Microsoft Office Suite
Ability to work off shift hours (weekends and some evenings).
Degree in Nursing
At least 2 years of clinical experience as a nurse and experience working in a hospital setting
Some research experience with clinical trials
Spanish language skills
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 508954
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.