The Pediatric Infectious Disease Division at Johns Hopkins School of Medicine is in search of a dynamic Clinical Research Nurse to join our dynamic and experienced team. The successful applicant will work collaboratively with a multidisciplinary health care/research team to promote quality and excellence of care, optimize team performance and achieve divisional clinical, research and organizational goals and outcomes.
The successful applicant will be working on diverse multi-phase research studies from a variety of sponsors, including investigator-initiated, network-based, NIH, and industry sponsors.
CLINICAL RESEARCH NURSE RESPONSIBILITIES INCLUDE:
A. 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.
With guidance, evaluates the impact on and availability of resources for assigned clinical trials.
Reviews prospective reimbursement analysis (PRA) as appropriate.
As appropriate & with guidance, prepares & submit application documents and forms to the IRB.
With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, lab requisitions, 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 (including: 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.
Conduct home visits to deliver intervention, medication, and draw blood
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 clinical research management system (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:
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 sponsor 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. B. 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.
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:
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 even.t
As appropriate, performs phlebotomy and IV insertion 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.
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 credentialing process.
Preferred Qualifications: Prior research experience preferred, but not required.
Additional Knowledge, Skills, and Abilities:
Highly effective verbal and written communication skills are required.
Must be able to perform venipuncture and draw blood
Sitting, standing and walking for extended period. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s). Ability to move standard equipment through a hospital or clinical environment.
Must have access to reliable transportation.
Possible exposure to communicable diseases, hazardous materials, and pharmacologic agents. Safety regulations must be followed.
Work schedules are determined by protocol requirements and activity and may demand flexible and/or extended work hours, including rarely weekends or holidays if needed (comp time provided).
Classified Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $60,945.00 - $83,865.00; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:00am - 4:30pm Exempt Status: Exempt Location: School of Medicine, East Baltimore Campus Department Name: Pediatric, Infectious Disease Personnel Area: Johns Hopkins University
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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