Sr. Research Nurse

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Apr 09, 2021
Employment Type
Full Time

General Summary/Purpose:

The Sr. Research Nurse will be responsible for the oversight of the administrative and scientific implementation of several complex clinical research studies at the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center. 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, Infection Disease Clinical Research Unit, IRB, sponsors (both NIH and commercial) and various other internal staff members on development, implementation, and management of various research studies. Responsible for coordinating multiple research studies in ambulatory and hospitalized patients with active infectious diseases, primarily involving the areas of virus and bacterial infections, including but not limited to SARS-CoV-2, hepatitis B virus, hepatitis C virus, HIV, and co-infections with viral hepatitis and HIV. As a senior research nurse coordinator, this individual will be responsible for IRB submission preparation and regulatory compliance per Food and Drug Administration guidelines, Department of Health and Human Services guidelines, Good Clinical Practice guidelines, and ICH guidelines. Knowledge of HIPAA requirements and human subjects training is required. Requires experience working with complex clinical protocols including phase I-IV studies and protocol adherence issues.

Specific Duties & Responsibilities

  • Nurse Coordinator for multiple research 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
  • Leadership:
  • 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
    • Patient assessment, prick skin testing, spirometry, oral food challenges, administer IV drugs, initial dose escalation visits, and up-doing visits.
    • 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
  • Data Management
  • Oversee the collection of study data, that includes ensuring data reflects the requirements of the study.
  • Oversee data query resolution
  • 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.
    • 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis.
    • Minimum of two (2) years’ experience in the specialty or a related area required.
    • 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.

    Classified Title:Sr. Research Nurse
    Working Title: Sr. Research Nurse
    Role/Level/Range: ACRP/04/MF
    Starting Salary Range: $70,805 - $97,437
    Employee group: Full Time
    Schedule: M-F 8:30am - 5pm
    Exempt Status: Exempt
    Location: 04-MD:School of Medicine Campus
    Department name: 10002794-SOM DOM Bay Infectious Disease
    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 atjhurecruitment@jhu.edu. 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.

    EEO is the Law
    Learn more:
    https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

    School of Medicine - East Baltimore Campus


    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 jhurecruitment@jhu.edu. 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.

    EEO is the Law
    Learn more:
    https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
    Important legal information
    http://hrnt.jhu.edu/legal.cfm

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