Clinical Research Nurse
2 months ago
Clinical Research Nurse I/II
6-month CTH
4 days onsite (10 hours)
POSITION SUMMARY
- Through the practice of professional nursing, maintain equilibrium between the care of the research participant and fidelity to the research protocol (ANA, 2016). Works independently under the general supervision of the Principal Investigator and/or other research department management. Provides guidance to Research Nurse I.
- Expected to function independently as a competent clinical research nurse, which is inclusive of but not limited to, familiarity and application of Good Clinical Practice (GCP) guidelines and Federal Regulations that govern the conduct of human subject’s research as well as Institutional Review Board, institutional and Perlmutter Cancer Center Clinical Trials Office policies and procedures related to human subject’s research; Demonstrates nursing skills as required under NY state and federal regulations for RN licensure; clinical assessment skills related to Adverse Events collection and related management; ability to navigate patients successfully through course of trial participation within assigned DMG and protocol literacy.
POSITION RESPONSIBILITIES
- Conducts a thorough research screening visit for potential trial participants, including a Review of Systems, baseline AE assessment and documentation, and collection of concomitant medications. Works with investigators to evaluate eligibility.
- Provide patients with thorough explanation of trial prior to obtaining Informed Consent, in collaboration with treating physician and provides patient education on an ongoing basis throughout the patient’s course on trial.
- Responsible for the good quality source documentation related to research visits, Adverse Events and Concomitant Medications.
- Completes research visits and obtain Informed Consent with non-English speaking individuals.
- Works with CRC 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 issues. Participates in the Feasibility meeting discussion and provides adequate explanation regarding clinically related obstacles.
- Reviews and approves protocol tracking forms prior to study activation.
- Develops and provides in-services for all approved protocols within DMG, on ongoing basis.
- Responds to queries requiring clinical input or changes to research nurse generated e-documentation.
- Provide timely follow-up to all clinical patient inquiries/concerns. Provide referral, follow up, and or medication management on as-needed basis.
- Maintain fluency in disease-specific terminology. Broad understanding of disease. 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. Providing timely updates to all of CTO team regarding changes in standard of care treatment modalities.
- Provide 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. Educate patients on the ongoing nature of the Informed Consent process.
- Review Beacon Build Template as completed by Physician Investigator for all trial patients enrolled onto clinical trials with assigned DMG. Ensure treatment plan is correctly built into Beacon Build Template.
- Oversees the clinical coordination of patient schedules ensuring overall adherence to protocol defined criteria.
- Provides guidance to Associate CRCs, CRCs, and Sr. CRCs and CRN 1 level staff.
- Ensure Serious Adverse Events and other reportable information is reported as per regulatory requirements and timeframes. Complete documentation related to Serious Adverse Events in required timeframe, for internal and external review. Provide follow up information, when clinically available, to Serious Adverse Event submissions.
- Maintains knowledge of current SOC and protocol-specific side effect management guidelines, including but not limited to: chemotherapy/immunotherapy guidelines and infusion reaction guidelines.
- 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.
- Additional responsibilities as needed including but not limited to participation in the development of SOP’s, policy changes, education sessions, and quality improvement projects.
MINIMUM QUALIFICATIONS
- RN/BSN; 2+ years’ experience in oncology research nursing with qualifying experience determined at the discretion of the Nurse Manager. New York RN Licensure and BLS.
- Expected to Obtain Chemotherapy/Immunotherapy certification within 6 months of moving into this role. OCN preferred, CCRP or CCRC preferred.
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