The Research Nurse will be responsible for the oversight of the administrative and scientific implementation of one or more Pediatric Gastroenterology and Hepatology studies. Provides clinical nursing care directly to patients/families involved in clinical research, through the integration of specialty knowledge and expert clinical reasoning and through the application of the nursing process in a research setting. Job requires utilizing a thorough knowledge of concepts and theories in research studies and associated protocols for the design, implementation, oversight and analysis of clinical trials. Job requires collaboration with faculty, research staff, clinical research unit staff, lab staff, IRB, external study sponsors and various internal staff members on development, implementation, and management of various research studies. Candidate will have a direct reporting relationship with the Principle Investigator(s).
Specific Duties & Responsibilities:
45% Study Nurse:
Pre-study: Anticipate research requirements for designated patient populations. Review and assess new protocols for clarity, feasibility, maintenance of subject safety. Review prospective reimbursement analysis (PRA) as appropriate.
Pre-initiation: As appropriate, prepare & submit protocol & consent forms to the IRB; prepare other forms required for study initiation (pre-printed orders, eligibility checklists, etc.). Determine that IRB approval has been received prior to initiation of research activity. Participate in study initiation meetings and prepare space for study-related equipment & supplies. Assist PI(s) implementation and coordination of assigned study/studies.
Recruitment & enrollment: Ensure subject eligibility for assigned research studies. Screen potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, and other relevant documents). As appropriate, obtain informed consent from research subjects. In conjunction with PI, monitor protocol enrollment goals.
Regulatory and document maintenance: Assist staff with necessary IRB training and other regulatory requirements. Develop, implement, and maintain SOPs. Based on study protocols create study documentation and case report forms. Based on research protocols design regulatory binders for studies and oversee maintenance for the life cycle of the study. Ensure that studies comply with applicable regulations and guidelines, including GCP, and that staff adhere to study protocols and procedures. Ensure that study is conducted according to all applicable regulations and guidelines and adhere to standard operating procedures specified in protocol manual.
Quality Assurance: Develop, implement and ensure compliance of QA/QC activities related to all studies. Recognize and document adverse events per protocol and ensure reporting to appropriate study & regulatory personnel. Initiate adverse event reports and ensure proper and timely distribution to sponsor and IRB. Prepare for and respond to study audits in a timely fashion.
Communication: Assist in completion of annual periodic review of data for reporting to IRB and sponsor. Communicate effectively with subject & family of active and prospective study participants. Communicate effectively and meet regularly with members of the research team to review protocol progress and data collection. Complete required documentation for accreditation and annual reviews in a timely fashion. Act as contact between PI(s) and other research sites and institutional partners. Participate in monthly/bi-weekly coordinator and committee calls as required by individual studies.
40% Nursing activities related to research:
Schedule, perform, and/or monitor procedures and tests per protocol requirements and to ensure results available in timely manner
Administer appropriate developmental assessments and questionnaires
Provide nursing care as needed for subjects/families in a research setting
Obtain and ensure proper distribution of required bio-specimens, including specimens obtained in clinical or operating room settings
Develop and/or ensure availability of appropriate protocol and treatment-specific patient education materials
Determine effectiveness of patient/family education and modify the education plan to most effectively address patient/family needs
Demonstrate and teach appropriate medication administration including subcutaneous injection and oral medication administration, storage to subjects/families
Monitor patient compliance with medication diaries
Assess and ensure subject safety throughout participation in trial
Monitor patients with medical problems related to study
Recognize common laboratory values and alerts appropriate individuals for clinically significant deviations
Present PI(s) with relevant information for determination of seriousness, causality, and intervention for adverse event
Act on the PI's recommendation for adverse event intervention
Maintain follow-up to determine resolution of adverse event
As appropriate, perform phlebotomy per policy and procedures
15% Data Management:
Obtain required data through chart review, telephone communication, subject interview and assessment
Monitor data compliance with requirements of assigned research
Complete data entry into study data systems in a timely manner
Respond to and complete data requests and query resolution by study sponsors in a timely manner
Perform other duties as assigned.
Minimum Qualifications (mandatory):
Must be a registered nurse, licensed in the State of Maryland or state where practicing.
Current CPR certification.
Bachelor's degree in nursing or related discipline preferred.
Master's degree strongly preferred.
Three (3) years as a registered nurse with a minimum of two (2) years of research experience; strongly preferred but not required.
Special Knowledge, Skills, and Abilities:
Ability to work independently, exercise discretion and mature judgment, and manage multiple priorities simultaneously.
Strong written, verbal, and interpersonal communication skills.
Detail oriented, well organized, self-motivated, time management skills, general computer knowledge.
Classified Title: Research Nurse Working Title: Research Nurse Role/Level/Range: ACRP/03/ME Starting Salary Range: $60,945-$83,865 (commensurate with experience) Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003078-SOM Ped Gastroenterology 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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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.