Research Nurse (Oncology)
Johns Hopkins University
We are seeking a Research Nurse who will reporting to the Research Nurse Manager, this position is 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's Degree in nursing or related discipline.
Classified Title: Research Nurse
Role/Level/Range: ACRP/03/ME
Starting Salary Range: $64,600 - $113,300 Annually ($104,040 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8a - 5:30p
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Onc Cancer Immunology/GI Clinical Re
Personnel area: School of Medicine