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Requisition ID:  116983

Sr. Research Nurse

The School of Medicine Pediatric Infectious Diseases is seeking a Sr. Research Nurse.  The Sr. Research Nurse is responsible for assisting with planning, implementing, and monitoring SMILE-TB while adhering to scope and timeline requirements, and assuring compliance with applicable regulations including GCP and ICH. They will be responsible for aspects of the implementation, management, and assessment of SMILE-TB and back-up other TA2 pediatric clinical trials. They will assist with: Manuals of Operations revisions and Standard Operating Procedures reviews; facilitate data management, data cleaning, and, occasionally, data analysis; prepare communications with institutional review boards; communicate with regulatory and funding agencies; other duties as assigned. They will plan and organize international activities, including fostering good communications and providing quality assurance for trials. International travel may be requested annually, depending on study progress and SMART4TB international team meeting locations. SMILE-TB clinical research site locations include South Africa, Uganda, Mozambique, Zambia, Indonesia and India.


Project summary

The U.S. Agency for International Development (USAID) launched the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) project. SMART4TB, a five-year $200 million initiative, to identify more effective methods and tools for finding, treating, and preventing tuberculosis (TB) in 24 priority countries for TB programming. This initiative will build research capacity in high TB burden countries by supporting studies that evaluate novel approaches, interventions, and tools to combat TB–including diagnostic tests, new treatment drugs and regimens, socioeconomic and health system challenges, methods to interrupt TB transmission, and TB vaccines readiness and delivery.


Within SMART4TB’s Technical Area 2 (TA2) focused on new treatment drugs and regimens and under the supervision of the Research Nurse Manager, they will independently support and manage aspects of the scientific implementation and operation of the international, pediatric clinical trial “Shortened Regimen for Drug-susceptible TB in Children (SMILE-TB). This is a grant-funded position through July 2027 contingent on the Agency’s continued support throughout the duration of the project period.


Specific Duties & Responsibilities

  • Prepare/review clinical trial documents including project agreements, CRFs and study plans/manuals, as appropriate.
  • Coordinate operational aspects of clinical trials.
  • Independently manage aspects of international clinical trial daily operations through to the final clinical study report.
  • Monitor timelines and project deadlines and apply clinical and operational knowledge to evaluate study progress.
  • Identify and anticipate potential study management or operations issues and collaborate with investigators and research staff to resolve these barriers to the study’s success.
  • Coordinate review by the clinical diagnosis and endpoint review committee.
  • Coordinate collection and cloud-based storage of digital x-rays from sites and review by central radiology team.
  • Review and revise training materials, including site initiation visit materials, clinical examination-specific trainings, and other trial-specific training opportunities, in consultation with the Research Nurse Manager and trial investigators.
  • Provide quality assurance oversight to preserve the rights and safety of research participants.
  • Propose and negotiate alternatives to improve study enrollment as needed.
  • Review trial operations to ensure that safety concerns and/or Adverse Events/SAEs and protocol deviations are properly reported and tracked.
  • Apply clinical and operational knowledge to compile and present regular trial status updates to the Principal Investigator and Protocol Team.
  • Review monitoring activities and escalate critical issues to the Research Nurse Manager.
  • Collaborate with Contract Research Organization (CRO) monitors to foster a productive and effective working relationship.
  • Conduct periodic review and revision of the Manual of Operations and site level SOPs to assure compliance with GCP and ICH policies.
  • Assure compliance with regulatory requirements ensure that the clinical trial(s) is always “audit ready”. Ensure that any audit observations are addressed appropriately and in a timely manner.
  • Maintain a platform for regular communication with the sites.
  • Develop agenda for regular multi-site teleconferences; ensure timely preparation and distribution of meeting minutes.
  • Prepare submissions to institutional review boards for study protocols, using IRB, and respond to queries, in consultation with the Research Nurse Manager.
  • Contribute to the research team in preparing abstracts and presentations related to research projects.
  • Attend virtual and in person meetings with site teams and the SMART4TB consortium.
  • Perform other related functions, as assigned.


Minimum Qualifications
  • Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required. 
  • Minimum of two years experience in the specialty or a related area required.
  • Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience


Preferred Qualifications
  • Pediatric and/or adolescent clinical experience.
  • Two years of experience working in high TB burden countries.
  • Master's degree strongly preferred.

 

 

Classified Title: Sr. Research Nurse 
Role/Level/Range: ACRP/04/MF  
Starting Salary Range: $75,100 - $131,700 Annually ($102,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F; 37.5 hours per week 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Ped Infectious Disease  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 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. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
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.
Hybrid: On-site 1-2 days a week

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