As the Research Nurse- Grant Funded you will implement and lead research projects involving direct patient care. You will coordinate, implement and adhere to research projects to assure research projects are carried out as approved by the Institutional Review Board (IRB). You will also work within the scope of practice to perform required protocol procedures, collaborate 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?istration (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?tion 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.
- 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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Please note: North Shore-LIJ is a smoke-free environment. Smoking and the use of tobacco products is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises. Free smoking cessation programs and quit medications are offered to team members who wish to quit through the North Shore-LIJ Center for Tobacco Control.