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