Northwell Health Research Nurse - North Shore University Hospital - Manhasset in Manhasset, New York
Req Number 002ZS0
Implements and leads research projects involving direct patient care. Coordinates, implements and adheres to research projects to assure research projects are carried out as approved by the Institutional Review Board (IRB). Works within the scope of practice to perform required protocol procedures. Collaborates with physicians, and other health/ancillary team members to promote study integrity and protocol compliance.
Participates in discussions regarding feasibility of protocol implementation based on knowledge of institutional capabilities and limitations, therapy, or population of interest.
Ensures initial and ongoing consent process is performed and documented in compliance with the U.S. Food and Drug Admin\xacistration (FDA), Good Clinical Practice, institutional policies, sponsor requirements, Institutional Review Board (IRB) and other applicable regulations, guidelines and policies.
Participates in the education of research subjects, families and health team members regarding study and significant new information arising during the conduct of the trial.
Collaborates with Principal Investigator (PI) to ascertain study patient eligibility for a clinical trial, including documenta\xaction of criteria specified in the protocol. Identifies and develops processes to overcome recruitment barriers.
Adheres to the protocol and other applicable requirements. Performs required procedures such as include administration of investigational agent (under PI supervision), electrocardiograms, placement of IV, catheters, phlebotomy, specimen collection, vital signs, subject assessment/questionnaire completion, adverse event assessment.
Collaborates with PI to assess patients for adverse events; documents and reports findings per protocol, FDA, sponsor, and IRB policies. Evaluates disease response results and physical assessment data in conjunction with the PI to determine response per the protocol (as applicable). Discusses protocol changes with PI, as necessary.
Administers, scores and evaluates assessments as assigned and as related to the study protocol. Collects data, confers with PI and forwards results to internal and/or external sponsors.
Collaborates with physicians, investigators, and other healthcare providers regarding subject care and safety as necessary. Promotes respect and advocates for the safety and care of clinical research subjects.
Facilitates and participates in the preparation for and implementation of audits including but not limited to the FDA, IRB and other external and internal monitors and auditors.
Interfaces with the Office of Grants and Contracts (OGC) and IRB to ensure all documents are processed and maintained per applicable regula-tions.
Collaborates with PI to organize all phases of grant process for submission to funding agencies and adherence to clinical trial agreement/study budgets, as required.
Ensures investigational agent availability and accountability.
Performs related duties, as required.
Bachelor's Degree in Nursing, required.
Current license to practice as a Registered Professional Nurse in New York State.
BCLS, ACLS, preferred.
Minimum of three (3) years nursing experience required, including one (1) year experience in Clinical Research, preferred.
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