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Research Nurse

Johns Hopkins University

East Baltimore, MD

Job posting number: #7077503

Posted: April 21, 2021

Application Deadline: Open Until Filled

Job Description

The Department of Oncology is seeking a full time 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.



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



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