Research Nurse (Oncology)

The Johns Hopkins University

Baltimore (MD)

On-site

USD 66,000 - 116,000

Full time

3 days ago

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Job summary

The Johns Hopkins University School of Medicine in Baltimore seeks a Research Nurse to coordinate and implement assigned clinical trials within the research program.

Reporting to the Research Nurse Manager, the role involves project management, protocol review, patient screening, consent, data collection, and ensuring subject safety across phases, with emphasis on collaboration with PIs, sponsors, and the healthcare team.

Qualifications

Registered Nurse licensed in Maryland.
BSN is preferred or may substitute experience where allowed by policy.

Responsibilities

Coordinate and implement assigned clinical trials.
Anticipate research requirements for designated patient populations.
Review protocols for clarity, thoroughness, and feasibility with guidance.
Obtain informed consent and prepare study documents per IRB requirements.
Monitor subject safety and report adverse events per protocol.
Maintain enrollment and data collection in CRMS and study files.
Communicate with PI, sponsor, and healthcare team to advance protocol goals.

Education

Bachelor of Science in Nursing (BSN)

Job description

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

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-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.
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.
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.

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.
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.

Education

Ensures that patient and staff education needs are met with regard to assigned protocols.
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.
Documents the implementation of nursing care & patient’s response in accordance with the established standards of internal & external agencies.
Performs complex treatments correctly & safely.

Minimum Qualifications

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