Department: Oncology; Cancer Immunology/GI Clinical Research
Status: Full Time
School: School of Medicine
Location: School of Medicine Campus
Location City: Baltimore
Location State: MD
Contact: Human Resources 410-955-2990
The Department of Oncology is seeking a Research Nurse. Reporting to the Research Nurse Manager, this position is responsible for the coordination and implementation of assigned clinical trials within the research program.
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.
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.
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline preferred. Oncology experience preferred. Current American Heart Association CPR certification required. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHH credentialing process is required prior to start date.
Additional Knowledge, Skills, or Abilities / Competencies: Highly effective verbal and written communication skills are required.
Working Conditions: Possible exposure to communicable diseases, hazardous materials, radiation, and pharmacologic agents, safety regulations must be followed. Work schedules are determined by protocol activity and may demand flexible and/or extended work hours.
Internal Number: 1113-en_US
About Johns Hopkins University
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.