A Brief OverviewThe Oncology Research Nursing Professional (ORNP) -is a Registered Nurse (RN) who works collaboratively with Clinical Research Staff including, but not limited to Physicians, Clinical Research Associates (CRA), APPs, Clinical Nurses, Pharmacists, and clinic staff to coordinate care for an assigned population of patients who are enrolled into cancer center clinical research trials. As the research expert of the multi-disciplinary team, the ORNP works independently and is accountable for the accurate conduct of their assigned cancer research protocol portfolio. Primary activities include educating the multi-disciplinary team on the protocol, setting up the operational workflows and ensuring the conduct of the research in adherence of good clinical practices. The ORNP works with the PIs on the assessment, management, and coordination of research patient care across the continuum of care (outpatient, inpatient and home) including triage of phone calls and proactive patient communication. The Oncology Research Nurse Professional -serves to educate patients and families on the clinical trial treatments, required testing, and protocol specific visits and expectations. Serves as lead for the disease center research portfolio and works with the Clinical Research Coordinator (CRCs) on the implementation, coordination, and documentation of trial specific requirements in alignment with all clinical trial and operational requirements.
LocationsStanford Health Care
What you will do- Clinical Trial Management
- Collaborates with the investigator and serves as lead on study patient screening, eligibility determination and enrollment assessments on assigned clinical trials, including documentation of criteria specified in the clinical trial.
- Uses independent judgement to assess, identify, and prioritize clinical information to physician, NP, PA and other clinicians for patients who are being evaluated and/or enrolled in a clinical trial.
- Assesses and documents signs and symptoms of illness, reactions to treatment, changes in physical or psychological condition and general appearance in accordance with the research protocol assuring that the documentation is complete and accurate to avoid protocol deviations.
- Manage patient/family phone calls - collaborating with MD, NP and/or PA as needed to obtain orders for the management of the patient.
- Manages and communicates all aspects of care as defined by the research protocol with the physician and other health care professionals and research team members.
- Collaborates with CRC to assure that therapeutic clinical trial flag is placed on the patient during active treatment. Removes flag when patient is removed from clinical trial participation or when treatment is complete.
- Plans, coordinates, and completes randomization (if applicable), patient assessments (toxicity assessment, diagnostic tests, and questionnaires), treatments and follow up care according to the defined protocol treatment plan (ensuring protocol adherence). Demonstrates ability to multi-task, prioritize effectively and attention to detail to avoid protocol deviations.
- Informed Consent Process
- Manages the consent process to ensure it is performed in compliance with institutional, FDA, IRB, clinical trial sponsor and other applicable regulations.
- Oversees and participates in the education of the patient regarding the clinical trial - documenting the education regarding the clinical trial in the medical record.
- Alerts principal investigator of any concerns raised by the patient during the informed consent process.
- Assures that the signed consent for the protocol is scanned timely into the medical record and aligns with institutional and sponsor processes for the clinical trial.
- Protocol Compliance
- Oversees and assists the CRCs with internal or external study monitors visits, site visits and study close-outs; and collaborates on the review of documentation during protocol audits.
- Develops protocol specific Beacon order sets (or paper if needed) in collaboration with the investigational pharmacy, nursing and principal investigator for therapeutic clinical trials. Assures that the orders are reviewed, approved and posted in Clinical Trials on Line (CTOL).
- Oversees and promotes compliance with protocol procedures and processes as outlined in the clinical trial.
- Collaborates with scheduling staff to assure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely.
- Develops and provides education to nursing staff as applicable regarding the clinical trial to assure that the protocol treatment plan is followed and that the medications are administered safely and as outlined in the clinical trial.
- Other
- Follows all institutional and regulatory guidelines, policies and procedures when providing care. Ensures adherence to GCP, ICH, FDA and other regulatory agencies in the conduct of clinical research.
- Provides care within the California Nurse Practice Act.
- Delivers population specific care taking into consideration issues related to age, culture and other social issues.
- Ensures work environment is organized and functions efficiently. Participates in a collaborative, positive work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationship within the disease cluster team and through the medical center.
- Maintains current knowledge and awareness of organizational and regulatory standards, policies, and procedures. Designs and provides training and guidance to operational teams.
- Accountable for the assessment of feasibility, workflow design, set-up and implementation of research specific programs and projects.
- Assist Principal Investigators in protocol development; contribute to analysis and interpretation of clinical results as appropriate; and present at local, regional and national research meetings/conferences as appropriate.
- Reports on activities and outcomes proactively.
- Performs other related duties as assigned or requested, functioning independently and follows through on assigned projects.
- Manages multiple clinical research tasks and projects simultaneously across various platforms.
- Interacts with senior and executive level staff and acts as the subject matter expert for clinical research matters.
- Acts as a preceptor/mentor for new research staff members and/or students as applicable.
- Communicates vetted clinical research information at all levels of the organization and with internal/external vendors as noted below.
- Internal Contacts: Disease program lead physician, NP, PA, Clinical Pharmacist, shared services staff and other health care professionals who may be involved in the care of assigned patients.
- External Contacts: Outside MD, Pharmaceutical sponsor (if applicable), home care agencies and/or community resources as applicable.
Education Qualifications- BSN or higher-level nursing degree required
- MSN highly preferred
- Masters in research or healthcare related field preferred
Experience Qualifications- 5 plus years nursing experience required -OR- 3+ years in an oncology research nurse role required
- 2 or more years of experience in oncology
- Experience in clinical research, research, ICU, other intensive care setting, pediatrics, case management or nurse navigation preferred
- Human subjects' protection and Good Clinical Practices training (can be completed after hire)
Required Knowledge, Skills and Abilities- Ability to communicate vetted information at all levels of the organization and with internal/external vendors.
- Ability to be highly- and multi- task focused while managing multiple tasks and projects simultaneously across various platforms.
- Ability to understand information flow and solve problems under pressure.
- Ability to manage conflict resolution.
- Ability to adapt and troubleshoot in a unique and quickly changing, fast-paced environment.
- Ability to work with ambiguity.
- Expert with Outlook scheduling, web ex, telepresence and other technology.
- Experience working in a team environment
- Experience interacting with senior and executive level staff.
- Experience managing work and relationships in a volatile environment.
- Excellent relationship building and stakeholder management skills.
- Independent, critical thinker.
- Demonstration of advanced written, verbal communication and facilitation skills.
- Read, understand, comprehend instructions with minimal directions.
- Understand and respond to multiple personalities and work/management styles.
- Resource management/utilization knowledge in projects.
- Financial and business acumen.
- Demonstrates advanced proficiency in the specific tools that are available and required as part of the organizations research management information system, analytics and metric management.
Preferred Knowledge, Skills and Abilities- Previous experience as an oncology research RN or clinical research in a related field
- Masters in a research related degree
Licenses and Certifications- CA-RN (Registered Nurse) .
- BLS - Basic Life Support .
- OCN-Oncology Nursing Certification preferred preferred .
- CCRP - Cert Clin Resch Professio preferred .
- ONS Chemotherapy/Biotherapy certification preferred
- ACRP - Association of Clinical Research Professionals preferred .
Base Pay Scale: Generally starting at $83.98 - $111.27 per hour
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training. This pay scale is not a promise of a particular wage.
