Research Nurse (Oncology)

Reporting to the Research Nurse Manager, we are seeking a Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program. Specific Duties & Responsibilities Project Management Pre-study * Anticipates research requirements for designated patient populations. * With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety. * With guidance, lists & clarifies concerns and questions about new protocols with PI and sponsor. * Reviews prospective reimbursement analysis (PRA) as appropriate. Pre-initiation * As appropriate & with guidance, reviews consent forms prior to submission to the IRB. * With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, etc.) * Determines that IRB approval has been received prior to initiation of research activity. * Participates in study initiation meetings. * Prepares space for study-related equipment & supplies. Recruitment & enrollment * Ensures initial & ongoing eligibility of all subjects for assigned research studies. * Screens potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, other relevant documents). * Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate. * Abstracts data from a variety of sources to complete pre-study work-up. * Demonstrates and participates in the informed consent process. * As appropriate, documents obtaining of informed consent in medical record. * Registers research subjects per sponsor guidelines. * In conjunction with PI, monitors protocol enrollment goals. * Demonstrates knowledge of protocol endpoint definitions. * In collaboration with healthcare team, evaluates potential subjects for research participation. Data collection/Document maintenance * Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials. * Obtains & ensures proper distribution of required pharmacokinetic & tissue samples. * Schedules, performs, and/or monitors procedures & tests per protocol requirements. * Ensures correct documentation of clinical study in medical record and appropriate protocol documents. * Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner. * As appropriate, ensures all required signatures are obtained on informed consent documents. * As appropriate, ensures validity of available informed consent documents. * Maintains CRMS data base for enrollment. * Reviews protocol amendments as required. * Develops procedure and collection forms for pharmacokinetic sampling. * With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment. * Coordinates with data managers to ensure delivery of trial data for inclusion into study files. * As appropriate, & with assistance as needed, orders required medical equipment & supplies. * Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data. * With guidance, organizes own time & sets priorities for research-related functions. * With guidance, able to prioritize workload & manage multiple projects effectively. * Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions. * Aware of & knowledgeable about departmental Standard Operating Procedures. Quality Assurance * Evaluates outcomes of assigned clinical trials. * Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB. * Grades identified toxicities per NCI or protocol-specific criteria. * Attends medical staff meetings to review study progress. * In collaboration with other members of the research team, prepares for and responds to study audits. Communication * With guidance, assists in completion of annual periodic review of data for reporting to IRB, protocol sponsors, & cooperative groups. * Documents written & verbal communication with study contacts. * Communicates effectively with subject & family of active and prospective study participants. * Communicates effectively with members of the health care and research teams. * Meets regularly with other members of the research team to review protocol progress and data collection. * Attends and participates in meetings of the research nurse group; completes required documentation for accreditation and annual reviews in a timely fashion. * Attains proficiency in Web-based communication. * Demonstrates understanding of the rules for advertising for subject participation, where appropriate. Education * Ensures that patient and staff education needs are met with regard to assigned protocols. * Patient/Family Education. * Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials. * Determines effectiveness of patient/family education & modifies the education plan to most effectively address patient/family needs. Staff Education * Identifies staff learning needs, including those based on requirements specific to designated research protocols. * Ensures development & availability of appropriate staff education materials. * Provides staff education related to assigned clinical trials (i.e., in-services). * Attends and participates in in service and external trainings, workshops, conferences, and other relevant and/or required programs for professional growth and development, Clinical Practice Planning * Organizes own time & sets priorities for a group of patients on a research protocol. * Plans for research related activities while understanding patient’s current medical problems. * Utilizes available resources to meet patient care needs. * Utilizes health care team members in planning care. * Coordinates care that involves other health care disciplines or resources to provide continuity and assist in patient compliance with protocol requirements. Implementation * Assesses and ensures subject safety throughout participation in trial; assists patients with medical problems related to study. * Recognizes common laboratory values and alerts appropriate individuals for clinically significant deviations. * Presents PI with relevant information for determination of seriousness, causality, & intervention for adverse events. * Acts on the PI’s recommendation for adverse event intervention. * Maintains follow-up to determine resolution of adverse event. * As appropriate, performs phlebotomy per policy & procedures. * Complies with institutional infection control policies. * Documents the implementation of nursing care & patient’s response in accordance with the established standards of internal & external agencies. * Performs complex treatments correctly & safely. * Documents telephone and other communications with patients per institutional policy. Evaluation * Evaluates effectiveness of nursing care given on a short-term basis. Consultation * Communicates data from clinical trials relevant to patient management to community-based health care personnel. Minimum Qualifications * Individual must be a Registered Nurse, licensed in the State of Maryland. * Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Preferred Qualifications * Bachelor of Science in Nursing Degree. * Oncology experience. * * * Classified Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $64,600 - $113,300 Annually ($90,000- 103,400 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Mon - Fri / 8:30a - 5p FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area: School of Medicine