Position Summary
Under the direct supervision of the Clinical Coordinator at the Harlem Prevention Center, 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.
Responsibilities
- 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%)
Minimum Qualifications
- Bachelor's degree and 4 years of related experience
- Degree in Nursing and current NYS RN license
- At least 2 years of clinical experience as a nurse
- 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).
Preferred Qualifications
- Experience working in a hospital setting
- Some research experience with clinical trials
- Spanish language skills
Other Requirements
Domestic travel, if needed