Reporting to the Principal Investigator(s) and to the Research Nurse Manager, this position is responsible for the coordination and implementation of assigned clinical trials within the Head and Neck Cancers Malignancies research program.
Specific Duties and Responsibilities:
A. Project Management
1. 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
With guidance, evaluates the impact on and availability of resources for assigned clinical trials
As appropriate & with guidance, prepares & submits documents 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
3. 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 understanding of the informed consent process
With guidance & as appropriate, obtains informed consent from research subjects
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
4. 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
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
5. Quality Assurance: 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
B. Education: Ensures that patient and staff education needs are met with regard to assigned protocols
1. 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
2. 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
C. Clinical Practice
1. 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
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
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
With guidance, provides supervision and oversight of Clinical Associates as assigned.
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.
Baccalaureate Degree in Nursing, or Registered Nurse with 2 years full-time clinical experience
Minimum of 2 years full-time clinical direct patient care experience; 3 years if non-BSN
Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of patients served. The individual must demonstrate knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient’s requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures.
Highly effective verbal and written communication skills are 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.
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/8:30am-5:00pm/37.5 hours Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002938-SOM Onc Upper Aerodigestive Cancer 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 [email protected]. 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.
Equal Opportunity Employer Note: Job Postings are updated daily and remain online until filled.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.