The Sr. Research Nurse will be responsible for the oversight of the administrative and scientific implementation of several complex clinical research studies. Provides advanced clinical nursing care directly to patients/families with complex care needs, 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, Pediatric Clinical Research Unit, IRB, sponsors (both NIH and commercial) and various other internal staff members on development, implementation, and management of various research studies. Candidate will have a direct reporting relationship with the Principle Investigator.
Specific Duties & Responsibilities
Nurse Coordinator for multiple research studies, primarily ARC-sponsored and NIH-PICNIC specific studies. Primary role is to assist PI with the development, implementation, management and coordination of multiple studies.
Writing and submitting IRB applications, renewals, and amendments and assisting staff with necessary IRB training requirements
Develops, implements, and maintains SOPs
Based on study protocols will create study documentation and case report forms
Based on research protocols will create and maintain Regulatory binders for studies and will 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.
Act as contact between PI and other research sites and institutional partners
Facilitate teamwork between research team, research pharmacy, research nutrition, research unit staff, study coordinating center and other sites.
Development and implementation of strategies for study recruitment and retention of participants
Maintain working relationships with other study teams both internal to JHU and external to Pediatrics
Develop, implement and ensures compliance of QA/QC activities related to all studies
Prepare site and staff for auditing and monitoring visits
Participate in Weekly progress meetings for active studies
Collaborates with PI to write job descriptions, interview, hire, train, mentor, motivate and lead additional study staff
Oversight of 1-2 research assistants.
Direct supervision of Study Coordinator – act as mentor and resource for recently promoted Study Coordinators, approve timesheets, evaluate and provide oversight of activities.
Present at national allergy research meetings
Nursing activities related to research include:
Provide advanced clinical care directly to patients/families enrolled in research studies
Identify and analyze staff, patient and system issues that impact our subjects in the research setting. Strategize and implement resolutions to better serve our subjects.
Provide nursing care as needed for subjects/families in a research setting
Oversee the collection of study data, that includes ensuring data reflects the requirements of the study.
Oversee data query resolution
Supervisory responsibility: 1 (one), Research Assistant II
Must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required. 2 years experience in the specialty or a related area required.
Additional experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience.
Master's degree strongly preferred.
Classified Title: Sr. Research Nurse Working Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $70,805 - $97,435; Commensurate with experience Employee group: Full Time Schedule: Monday-Friday, 8:30am-5:00p, Up to 37.5 hours/week Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003081-SOM Ped Immunology 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@example.com. 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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