Clinical Studies Registered Nurse II, Comprehensive Cancer Center

Provides specialized nursing care/treatment to a specific group of patients who are participating in clinical research studies within the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC). Functions as part of a research team that may consist of Investigators, Clinical Studies Coordinators, Data Managers, Regulatory Coordinators, and other Nursing Staff. Under the direction of the Investigator, the Clinical Research Nurse II is responsible for subject recruitment, eligibility, enrollment, informed consent, retention, education, and protocol adherence. Clinical responsibilities include monitoring toxicities, assessing clinical response and providing exemplary patient care while ensuring the protocol is conducted in a high-quality manner. Conducts clinical research in compliance with Clinical Protocol and Data management (CPDM) unit, State, and Federal guidelines. In addition, communicates research-related information to patients, families, nursing, and medical staff as necessary. Provides cross coverage as needed in the Cancer Center's Clinical Protocol and Data Management (CPDM) unit. Cross trains to support the other Clinical Studies Nurses when needed. Coordinates efforts related to clinical oncology studies, including investigator-initiated or investigator-initiated industry-sponsored clinical trials. Primary areas of focus are cross-departmental trials in several areas (treatment trials, supportive care, cancer prevention and control).

EDUCATION/EXPERIENCE

Associate's degree in Nursing from an accredited School of Nursing with one year of nursing experience, preferably in a related field, research, acute care, or a specialty area (specifically, Oncology). Bachelor's degree in Nursing with two or more years of nursing experience strongly preferred . Documented education and/or training in the oncology field preferred. LICENSURE, CERTIFICATION, and/or REGISTRATION Licensure as a Registered Nurse (RN) in the State of applicable state required. Must complete the CITI certification for Human Subject Research if not already completed and any additional required WakeOne training for research coordinators.

ESSENTIAL FUNCTIONS

Works under the direction/supervision of the Study Investigators, Disease Team Chair, and the Clinical Research Nurse Manager. Also receives supervision and mentoring from the Nurse Team Leader. Works in conjunction with a Research Nurse mentor and the oversight of a Nurse Team Leader to assume gradually more responsibility and workload. Knowledge and understanding of policies, procedures, and regulations governing human subject's research incorporates them in the conduct of research and care of participants. Actively screens patients for protocol enrollment, utilizing knowledge of oncology nursing to review pathology, laboratory results, scans and physician notes to verify patient eligibility. Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants. Coordinates patient schedules and provides information for a successful visit to meet the required protocol procedures, data collection time points and nursing care. With supervision, manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies. Serves as a nursing expert of specialized patient care, including direct patient care, assessment, documentation, treatment intervention and patient/family education and support in accordance with education/experience, established policies and procedures, and state licensure requirements. Works with WFBCCC investigators and staff to maximize identification of eligible study patients for recruitment to research protocols either by referrals or from the current pool of clinical patients. Recruits, consents, and enrolls patients onto trials once eligible patients are identified. Tracks new and follow-up patients for eligibility and recruitment: a. Enters patient status information into the cancer center database b. Records eligibility assessment and outcome c. Educates other clinic staff and physicians regarding protocol specific requirements Follows care of protocol patients while on protocol treatment to include the following: a. Coordinates with the physician and clinic staff to assure that all protocol requirements are scheduled and ordered b. Reviews EPIC/WakeOne to ensure protocol compliance and appropriate data collection; verify that all appropriate labs and measurements are performed and ordered correctly c. Ensures that charts are clearly labeled for the appropriate drug d. Assesses and enter the initial adverse event report and serious adverse events into the eIRB system e. Follows-up with the assigned regulatory contact to resolve any outstanding reporting requirements in a prompt and appropriate manner f. Provides constant communication with the assigned protocol specialist/data manager for all event reporting and for all needed data points g. Links research encounters appropriately to facilitate the correct invoicing of research specific activities. Performs the following ancillary duties: a. Collects blood samples (e.g. pharmacokinetic samples) and draw blood as necessary, running to special hematology, as necessary b. Collects data and blood work for protocols to maintain protocol requirements c. Works with home health, primary care physicians and affiliates to arrange follow-up and treatment d. Promotes communication and collaborative activities between Radiation, Gynecological, Surgical and Medical Oncology staff, special laboratory staff, research personnel and investigators for multi-disciplinary (multimodality) research studies to ensure quality patient care, efficient and effective operation of protocol processes, and achievement of study-related objectives, especially accrual enhancement for WFBCCC studies. Attends relevant investigational and professional meetings to keep abreast of current developments in the field. Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and public responsible for, or concerned about, protections for human participants of research. Performs other related duties incidental to the work described herein.

SKILLS/QUALIFICATIONS

Good oral, written, listening, and interpersonal and communication skills Ability to provide indirect patient care EPIC/WakeOne proficiency to include appropriate documentation of research notes Basic computer skills required

WORK ENVIRONMENT

Fast paced, long hours, ability to deliver results Professionalism and customer service skills being a must at all times Occasionally subject to irregular hours #J-18808-Ljbffr Advocate Aurora Health