Clinical Research Nurse I-Oncology

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Position Summary

We have an exciting opportunity to join our team as a Clinical Research Nurse I-Oncology.

Through the practice of professional nursing the Oncology Clinical Research Nurse (RN) I prioritizes and advocates for the best interest of the patient enrolled on an oncology clinical trial while maintaining the fidelity of the clinical research protocol and compliance with policies, procedures and regulations.

The oncology clinical research nurse works independently under the general supervision of the Clinical Trials Office Management and Leadership and the Principle Investigator for the specific protocol in order to competently support the safe, high quality and compliant conduct of oncology clinical research and ensure the protection of the patient.

The primary purpose of the subspecialized oncology clinical research nurse role is to facilitate positive outcomes of safety and quality for patients enrolled on adult oncology clinical trials at the NYU Perlmutter Cancer Center by coordinating and managing patients enrolled on clinical trials by employing the nursing process, clinical skills, critical thinking, evidence-based nursing and an understanding the scientific research.

The oncology clinical research nurse I is expected to develop and maintain competencies in clinical research nursing in the first year of the position including but not limited to comprehension and compliance with all NYU PCC Clinical Trials Office policies and procedures, NYU OSR and IRB policies and procedures, familiarity and application of Good Clinical Practice (GCP) guidelines and Federal Regulations that govern the conduct of human subjects research.

The oncology clinical research nurse I demonstrates nursing skills as required under NY state and federal regulations for RN licensure and the ability to navigate patients successfully through the course of trial participation within assigned DMG from pre-screening through coming off protocol.

Job Responsibilities

1. Collaborates with healthcare colleagues across all units and departments and with physicians and advanced practice providers utilizing the Ambulatory Care Practice Model.

2. Utilizing the nursing process, nursing assessment skills and critical thinking the Oncology CRN I conducts a thorough research screening visit for potential trial participants per the protocol requirements, including but not limited to a Review of Systems (ROS), baseline and ongoing AE assessment and documentation, and collection of concomitant medications and documents the assessments in the EPIC electronic health record per CTO policies and procedures.

3. Collaborates with investigators and study team members to recruit, enroll and retain patients on clinical trials while ensuring patient safety and protocol fidelity.

4. Collaborates with investigators to evaluate patient eligibility for the specific study.

5. Prepares for and oversees the safe conduct of study treatment visits per protocol.

6. Provides patients with a thorough explanation of a trial prior to obtaining Informed Consent and as part of the ongoing Informed Consent process, in collaboration with the treating physician and provides patient education on an ongoing basis throughout the patient’s course on trial.

7. Responsible for good quality source documentation related to research visits, Adverse Events and Concomitant Medications in compliance with CTO policies and standard operating procedures.

8. Supports and documents the Informed Consent process with non-English speaking individuals per institutional and external regulatory bodies policies and procedures.

9. Collaborates with the CRC(s) in establishing the feasibility, or lack thereof, on protocol implementation based on knowledge of institutional capabilities and limitations, therapy and population of interest; identifies potential feasibility barriers and communicates them to management promptly.

Participates in the Feasibility meeting discussion, and provides adequate explanation regarding clinically-related obstacles and potentially relevant solutions in collaboration with nursing and program management.

10. Creates, reviews and approves protocol tracking forms prior to study activation ensuring a double-check process of review within each assigned DMG for each unique protocol and protocol amendment.

11. Learns to develop and independently conduct outpatient and inpatient infusion nursing in-services for all approved protocols within the DMG and on ongoing basis as needed.

12. Supports the safe conduct of elective inpatient admissions for applicable clinical trials in collaboration with the study team, treating investigator and/or PI and management.

13. Provides cross-coverage for other DMGs as needed.

14. Responds promptly to queries requiring clinical input or changes to research nurse generated electronic documentation.

15. Provides timely follow-up to all clinical patient inquiries/concerns. Provides referral, follow up, and or medication management on as-needed basis. Triages research related patient communication in a timely manner and under the direction of the treating investigator. Collaborates with other NYU and PCC departments to resolve patient-related inquiries/concerns.

16. Maintains fluency in disease-specific terminology. Broad understanding of disease(s). Fluency in standard of care treatment modalities; keeping up to date with changes to standard of care treatment modalities for specific disease(s) within each DMG. Provides timely updates to all of CTO team members regarding changes in standard of care treatment modalities.

17. Provides clinical education to patients on ongoing basis, including but not limited to the following areas: understanding the disease process, understanding the protocol-specified treatment, understanding potential side effects, providing education regarding side effects management, providing education regarding laboratory abnormalities, interpreting and providing education related to scan results. Educates patients on the ongoing nature of the Informed Consent process.

18. Reviews the Beacon Build Template in collaboration with the Physician Investigator for all trial patients enrolled onto clinical trials within the assigned or covering DMG. Ensures treatment plan is correctly built into Beacon Build Template and communicates promptly with the Investigational Pharmacy team to ensure timely completion.

19. Oversees the clinical coordination of patient schedules ensuring overall adherence to protocol defined criteria.

20. Provides guidance, training and education to Associate CRCs, CRCs, and Sr. CRCs.

21. Ensure Serious Adverse Events and other reportable information is reported as per regulatory requirements and protocol, institutional and regulatory timeframes. Completes documentation related to Serious Adverse Events in required timeframe, for internal and external review. Provides follow up information, when clinically available, to Serious Adverse Event or Medical Event/Reportable New Information submissions.

22. Maintains knowledge of current SOC and protocol-specific side effect management guidelines, including but not limited to: chemotherapy/immunotherapy guidelines and infusion reaction guidelines.

23. Performs medication review, education, and reconciliation. Investigational medication handling: verification of drug, doses taken, diary review, reconciling discrepancies, education/re-education and proper return of unused drug.

24. Demonstrates regular attendance and maintains a record of attends for unit-based and department staff meetings and educational sessions.

25. Achieves and maintains the requirements of the oncology clinical research nurse ladder demonstrating ongoing professional growth.

26. Additional responsibilities as needed including but not limited to: supports the development of SOP’s, policy changes, education sessions, quality improvement projects.

27. Is flexible to support clinical care needs as the assigned DMG and day off are based on CTO, PCC clinical care needs.

28. Performs other duties as assigned.

Minimum Qualifications

To qualify you must have a BSN and New York RN Licensure and BLS. Maintenance of Chemotherapy/Immunotherapy certification through ONS required within the first year of the role. Minimum of 1+ years nursing experience in oncology research nursing or oncology nursing with qualifying experience determined at the discretion of the Director, Clinical Operations.

• Computer literacy including word processing, spreadsheet and database management skills
• Excellent analytical, interpersonal, writing and verbal communication skills.
• The ability to manage priorities and deadlines and maintain s