Research - Laboratory/Non-Laboratory, Staff/Administrative
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:
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
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 ofrequired pharmacokinetic & tissue samples
Schedules, performs, and/or monitors procedures & tests per protocol requirements
Ensures correct documentation of clinical study in medical recordand 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
Evaluates outcomes of assigned clinical trials
Recognizesand documentsadverse eventsper 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.
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
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
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
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
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
Communicates data from clinical trials relevant to patient management to community-based health care personnel
Minimum Qualifications (mandatory):
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.
Current American Heart Association or American Red Cross CPR certification required. Must maintain current licensure and certification during duration of employment.
Acceptable completion of the JHH or BMC credentialing process is required within two weeks of start date.
Oncology experience preferred
Licensure, Certification, Registration:
Current licensure in the State of Maryland as a Registered Nurse required
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.
Special Knowledge, Skills, or Abilities / Competencies:
Highly effective verbal and written communication skills are required.
Classified Title: Research Nurse Working Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $60,945-$83,865 Employee group: Full Time Schedule: Monday-Friday/9:00am-5:00pm/37.5 hours Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 60005128-SOM ONC Immunology Clinical Research Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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