About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.Position Summary and Key Responsibilities:
The Community Practice Clinical Research Nurse (CRN) is a Registered Nurse (RN) who works collaboratively with physicians, Clinical Research Site Schedulers (CRSSs), Clinical Research Coordinators (CRCs), Regulatory Coordinators (RCs) and pharmacists to coordinate care for an assigned population of patients who are enrolled onto IRB approved clinical research trials. The CRN assists in the assessment, management and coordination of outpatient care including triage of phone calls and proactive patient communication. The CRN serves to educate patients and families on the clinical trial treatments and required testing. The Clinical Research Nurse in collaboration with the CRC is responsible to ensure that the documentation for the clinical trial is complete and accurate. Key Responsibilities:
Informed Consent Process
- Management of Clinical Trials Patient
- Utilizes the City of Hope nursing process in clinical practice.
- Provides direct patient care for research related procedures for research patients, such as phlebotomy, including central lines, nursing assessments, and triage for research patients.
- Collaborates with the investigator to ascertain study patient eligibility for clinical trial, including documentation of criteria specified in the clinical trial.
- •Assesses, identifies and prioritizes clinical information to physician, NP, PA and other clinicians for patients who are being evaluated or who are enrolled onto IRB clinical trials.
- Assesses and documents signs and symptoms of illness, reactions to treatment, changes in physical or psychological condition and general appearance in accordance with the IRB protocol assuring that the documentation is complete and accurate in order 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.
- Coordinates and communicates all aspects of care as defined by the protocol with the physician and other health care professionals and research team members.
- Collaborates with CRC to ensure that therapeutic clinical trial flag is activated in the patient's EMR records 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.
- Collaborates with the physician and investigational pharmacists to ensure orders for treatment are written per protocol and delivered at the prescribed protocol intervals.
- Ensures that all documentation and required protocol documents are completed timely, completely and are legible.
- Collaborates with members of the interdisciplinary team to develop and implement the plan of care for the patient.
- Collects information from patient medical record, patient interviews, and diagnostic tests to determine eligibility of patient to be enrolled in the clinical trial. Communicates outcomes of eligibility to the physician.
- Supports and evaluates patient adherence to protocol and documents any deviations for adherence in the medical record.
- Collaborates as applicable with CRC for patients enrolled in clinical trials.
- Provides and documents education of patient and/or family regarding disease, treatment plan and follow up care.
- Administers (if applicable) and documents medications and evaluates the patient's response to treatment. Ensures that the delivery of medication is safe and follows COH policies and procedures.
- Utilizes resources to learn about new medications or medications that are a part of an investigational research protocol.
- Participates in team meetings and other sponsor meetings as applicable.
- Provide research patients with information associated with participation in a clinical research study: this includes both verbally and visually (paper or e-consent).
- Ensures the participant has adequate time to review the consent and ask questions.
- Responds to any inquiries about the study by the participant or family members.
- Alerts principal investigator of any concerns raised by the patient during the informed consent process.
- Ensure participant understands full the research project and able to freely give consent.
- Ensure all COH, federal and state regulations are followed for consenting non-English speaking patients or those whom cannot read, either English or their native language.
- Documents the consenting process in the electronic medical record (EMR).
- Conducts the consent process in compliance with any additional institutional, FDA, IRB, clinical trial sponsor and other applicable regulations.
- Ensures the consent process is performed and documented in compliance with institutional, FDA, IRB, clinical trial sponsor and other applicable regulations.
- Ensures that a copy of the signed consent is given to the patient and that it is scanned timely into the medical record.
- Ensures patients are appropriately scheduled, registered; maintains documentation of patient registration.
- 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.
- Demonstrates ability to multi-task, prioritize effectively and attention to detail to avoid protocol deviations.
- Assists internal or external study monitors in the protocol initiation and collaborates the review of documentation during protocol audits.
- Develops in collaboration with the investigational pharmacy and the principal investigator, study specific Beacon treatment plans for therapeutic clinical trials in EPIC. Ensures that the orders are reviewed, approved and published for use.
- Collaborates with principal investigators and Protocol Content Specialists (PCA) to ensure patient study calendars are created and accurately built within the clinical trials management system (OnCore).
- Promotes compliance with protocol procedures and processes as outlined in the clinical trial.
- Complies with the International Air Transport Association and institutional policies for shipping and receiving of biological specimens, experimental agents and devices.
- Provides education to nursing staff as applicable regarding the clinical trial to ensure that the protocol treatment plan is followed and that the medications are administered safely and as outlined in the clinical trial.
- Collaborates with scheduling staff to ensure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely.
Minimum Education and Skills Required for Consideration:
- 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 Modality team and through the medical center.
- Follows all COH policies and procedures when providing care. Provides care within the California nurse practice act. May provide direct clinical care to research patients.
- 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 community practice research team and the clinical staff.
- Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures.
- Is self-motivated in organizing and follows through on assigned projects.
- Acts as a preceptor/mentor for new staff members and/or nursing students as applicable.
- Internal Contacts: Disease program lead physician, NP, PA, Clinical Pharmacist 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.
- Practices a high level of integrity and honesty in maintaining confidentiality.
- Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationship within the research team and throughout the medical center and medical foundation.
- 2 or more years of experience in oncology AND 2 or more years of experience in clinical trials research: OR
- If prior clinical trial research is not oncology related, then a minimum of 4 years of non-oncology related clinical trials experience
Preferred education, experience and skills:
- Req. Certification/Licensure: Current California RN License, American Heart Association BLS Certification
- ONS Chemotherapy/Biotherapy certification (can be completed within 1 year of hire date)
- Human Subjects Protection training (can be completed after hire)
- Previous experience as a clinical research RN
- Nursing with previous oncology or clinical trial experience
- Status: Full Time
- Shift: Days
- Department: Clinical Research - So. Pasadena Clinic
- Please upload a current resume, RN license, BLS Card, and any additional certifications under the "attachments tab" on the application.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
- Posting Date: Jun 18, 2021
- Job Field: Clinical Research
- Employee Status: Regular
- Shift: Day Job