Study Nurse - Full-time / Part-time

This position is grant funded.

LOCATION: East 158th Street, Bronx, NY

POSITION SUMMARY:

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 Nurse 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 Study Nurse will perform phlebotomy, IV placement, obtain informed consent, and assist with other HIV prevention clinical trials as needed. Over the course of the study, responsibilities will shift to reflect the phase of the study. The Study Nurse will also implement the quality assurance and quality control (QA/QC) plans for the Bronx Prevention Center.

MAJOR ACCOUNTABILITIES:

* Conduct HIV counseling and testing, informed consent, phlebotomy, assist with medical exams, and complete study documentation.

* Insert IV's, start infusions, monitor infusions and complete infusions of the study product per study protocol procedures.

* Set up examination rooms and instruments in accordance with protocol needs and proper sterilization techniques

* Identify and report to the study clinicians any adverse events that are noticed and/or reported by study participants.

* Implement study-specific QA plans

* Check source documentation and case report forms for completion and accuracy, and correct data errors when present.

* Assist with preparation for any monitoring visits; address QC queries and respond to QC items on periodic QC reports from sponsor.

* 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

TRAVEL REQUIREMENTS:

* Occasional domestic travel to research training and meetings (1-2 times per year, approximately 3 days each) Minimum Qualifications for Grade

Applicant MUST meet these minimum qualifications to be considered an applicant - Requires a Bachelor's degree in Nursing and graduation from an accredited Nursing program.

* Current New York State RN license.

* To be considered for this position, please complete the master application in its entirety, including all work history and education. Additional Position-Specific Minimum Qualifications

Applicant MUST meet these minimum qualifications to be considered an applicant - 4+ years of clinical experience as a nurse

* 2+ years of research experience with clinical trials

* Demonstrated experience in QA management

* Demonstrated 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 Special Instructions Preferred Qualifications - Experience working with populations at elevated risk of HIV acquisition, such as men who have sex with men and transgender individuals

* Fluent in Spanish Essential Functions - Conduct HIV counseling and testing, informed consent, phlebotomy, assist with medical exams, and complete study documentation. (15%)

* Insert IV's, start infusions, monitor infusions and complete infusions of the study product per study protocol procedures. (10%)

* Set up examination rooms and instruments in accordance with protocol needs and proper sterilization techniques. (10%)

* Identify and report to the study clinicians any adverse events that are noticed and/or reported by study participants.(10%)

* Implement study-specific QA plans. (10%)

* Check source documentation and case report forms for completion and accuracy, and correct data errors when present.(10%)

* Assist with preparation for any monitoring visits; address QC queries and respond to QC items on periodic QC reports from sponsor.(10%)

* Maintain confidentiality of study participants and adhere to principles of Human Subjects Protection (HSP) and Good Clinical Laboratory Practice (GCLP). (10%)

* 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.(10%)

* Perform other related duties as assigned.(5%) Additional Essential Functions (Limit to 3950 characters.) Special Indications

This position works with: Bloodborne pathogens

Contact with patients and/or research subjects