The Center for Immunization Research is seeking an Adult Nurse Practitioner (NP) to assist with studies of vaccines in adults. The NP will work closely with the Principal Investigators, Physician Assistant, and Research Coordinators to implement vaccine trials in adult human subjects according to good clinical practice guidelines. These trials will be both in the inpatient and outpatient setting.
Specific Duties: Reviews medical histories and performs comprehensive screening physical examinations to determine eligibility of research subjects enrolled in clinical trials. In collaboration with the Principal Investigator, reviews and interprets laboratory studies and evaluates initial and ongoing eligibility of subjects enrolled in the clinical trial. Obtains interim histories and performs physical examinations during study visits. Refers subjects for additional medical care as appropriate.
In collaboration with the Principal Investigator, assesses adverse events occurring during the clinical trial for causality and severity. Responsible for 24 hour protocol accountability. Assists Principal Investigator in the preparation of safety reports to the Data and Safety Monitoring Board, to the Sponsor, to the Institutional Review Board, and to any other appropriate regulatory agency.
Responsible for administration of study material, surveillance, collection of specimens, data collection including but not limited to study documentation, maintenance of subject medical and research records, maintenance of written study related logs, shipping lists, drug accountability.
Contributes to development of semi-annual and annual reports to the Sponsor. Ensures compliance with protocol requirements. Ensures that all clinical trial related activity is performed in compliance within GCP, ICH, IRB guidelines, and other pertinent regulatory agencies.
Responsible for overall planning, implementation and evaluation of adult research studies in the following areas: protocol development, creation/selection of protocol data collection documents, site logistics including resource needs, orientation of study staff to protocol, adherence by staff to protocol, guide study staff in the day to day operations of the study, oversight of data collection.
Responsible for recruiting, screening, educating, obtaining informed consent. Participate in, and possibly organize, weekly progress meetings. Contribute to development of SOPs and update as needed. Holds self- accountable for professional, responsible conduct. Demonstrates excellent written, verbal, and interpersonal communication skills. Detail oriented, well-organized, self-motivated, superior time managements skills. Facilitate clinical and research laboratory work flow. Identification of resource needs (human, timelines, and facilities) and act as contact between temporary staffing agencies, outside agencies, institutional partner, CIR staff, and other agencies involved in these studies.
Administer study materials (i.e., vaccine). Provide input into operational project procedures. Responsible for ongoing quality assurance and quality control of protocols, day-to-day operations of the study, and data management. Devise and implement quality control measures as needed.
Participate in marketing, education, and outreach activities regarding protocol activities.
Perform reasonable job duties, even if not part of the job description, as assigned by the Principal Investigator.
Master's degree in nursing; Registered Nurse license and Certified as a Nurse Practitioner. Must be licensed as NP in State of Maryland or other state where practicing. Three years of related experience in adult clinical care preferred. CPR certification required and must be maintained.
Additional Knowledge, Skills and Abilities: Requires working knowledge of Microsoft office suite. Will require use of Microsoft Office Sharepoint, NIH database (CRIMSON), online specimen inventory program (FreezerPro). Training will be provided.
Oto-opthalmascope, sphygmomanometer, stethoscope, and pertinent laboratory equipment as needed for processing subject specimens.
Ability to effectively communicate and interact with Faculty Investigators, staff, and various JHU or JHSPH offices. Will also communicate with Sponsors, monitors, regulatory agencies, potential research subjects; research subjects.
Working Conditions: Requires the ability to flex schedule at the supervisor's request to work some evenings or weekends as required by study needs. However most work will be accomplished during normal clinical research hours.
Will require foot travel within the JHMI campus, particularly between the clinic on Broadway Street and the laboratory on Wolfe Street. Occasional require travel to the inpatient unit on the Bayview campus.
Physical Requirements: Finger dexterity required to manipulate objects with fingers rather than with whole hands or arms, for example, using a keyboard. Reaching by extending hands or arms in any direction. Occasionally lifting, carrying objects weighing 50 lbs or less. Occasionally pushing, pulling objects weighing 50 lbs or less. Ability to stand, walk or sit for an extended period of time. Ability to move about.
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