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Sr. Research Nurse

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Date posted
Feb 14, 2024

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Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

This is a grant-funded position for Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB), a USAID-funded initiative to improve global TB control. We are seeking a Sr. Research Nursewho will support PRISM Kids, a study evaluating new short course drug-resistant TB regimens in children. PRISM-Kids is a phase II, open-label, multicenter trial. The main objectives are to determine if treating children under age 14 years with DR-TB with and without HIV with a four to six month all-oral, once-daily regimen is safe and results in favorable TB-related outcomes at end of treatment and at week 52. Participants will be stratified at the beginning of the study on the basis of disease severity into one of two groups: a 4-month duration or a 6-month duration of treatment.

The Sr. Research Nurse is responsible for assisting with planning, implementing, and monitoring the PRISM-Kids trial, from protocol design to regulatory submissions to the final clinical study report, while adhering to scope and timeline requirements, and assuring compliance with applicable regulations including GCP and ICH. They will independently manage the scientific implementation and operation of PRISM Kids in concert with the study PIs and act as a liaison for the studies with the protocol team, international sites, regulatory agencies, study monitors, and administrators. They will be responsible for planning the implementation, management, and assessment of clinical trials led by investigators in the Center for TB Research. They will assist with aspects of protocol development, initiate and create case report forms, design Manuals of Operations, oversee implementation of Standard Operating Procedures at the site level, facilitate data management, data cleaning, and, occasionally, data analysis; prepare communications with institutional review boards, as well as communicating with regulatory and funding agencies, and other duties as assigned. They will plan and organize international activities, including fostering good communications and providing quality assurance for trials.

Specific Duties & Responsibilities

  • Contribute to the development of the PRISM Kids protocol, informed consents/assents, and clinical study reports; prepare/review clinical trial documents including project agreements, CRFs and study plans/manuals, as appropriate; and coordinate operational aspects of PRISM Kids
  • Independently manage the implementation and daily operations from protocol design to the final clinical study report. Define timelines for study start-up and apply knowledge to evaluate progress.
  • Maintain communications with a multi-disciplinary trial team made up of both internal and external team members, including but not limited to the study clinicians, site staff, contractual clinical monitor(s), vendors, data managers, and administrative staff.
  • 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.
  • Develop or oversee the development of training materials, including site initiation visit materials, clinical examination-specific trainings, and other trial-specific training opportunities, in consultation with investigators.
  • Conduct at least quarterly in-person or virtual site visits to monitor operations and provide quality assurance oversight to preserve the rights and safety of research participants.
  • Propose and negotiate alternatives to improve project implementation as needed.
  • Provide overall management to ensure that safety concerns and/or Adverse Events/SAEs and protocol deviations are properly reported and tracked
  • Coordinate with data management team to compile and disseminate regular trial status updates to the Principal Investigator and Protocol Team.
  • Oversee monitoring activities and escalate critical issues to the Principal Investigator.
  • Collaborate with Contract Research Organization (CRO) monitors to foster a productive and effective working relationship.
  • Initiate and conduct periodic review and revision of the Manual of Operations and site level SOPs to assure compliance with GCP and ICH policies
  • Develop agenda for regular multi-site teleconferences. Prepare and distribute meeting minutes in a timely fashion.
  • Develop and maintain a platform for regular communication with the sites.
  • Contribute to the research team in preparing abstracts and presentations related to research projects.
  • Perform other related functions, as assigned.

Regulatory

  • Implement a robust quality management system to ensure compliance with JHU and USAID requirements.
  • Serve as the primary resource for all PRISM Kids regulatory matters.
  • Prepare submissions to institutional review boards for study protocols, using IRB submission platforms, and respond to queries, in consultation with the Principal Investigator.
  • Perform other related functions, as assigned.


Supervisory Responsibilities

  • Orient and train new staff on PRISM Kids study materials, including JHU and international research site staff.
  • Provide guidance and mentorship to junior investigators and coordinators on international research implementation.
  • Supervise all PRISM Kids study staff based at JHU.

Special Knowledge, Skills, & Abilities

  • Excellent organizational skills.
  • Excellent attention to detail.
  • Excellent ability to manage multiple and competing priorities.
  • Excellent time management skills, with demonstrated ability for self-direction and initiation.
  • Strong oral and written communication skills
  • Ability to work independently.
  • Demonstrated ability to work well with other professionals with minimal supervision
  • Comfortable being part of a diverse, international team.


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 infectious disease or a related area
  • Ability to travel internationally several times annually, depending on study progress and international public health advisories.
  • Additional experience may substitute for bachelor's degree and related master's Degree may be considered in lieu of experience.


Preferred Qualifications
  • Master's Degree strongly preferred.
  • Prior experience working in developing countries is preferred.

Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: Min $74,400 - Max $130,400 ($115,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Monday-Friday, 8:30am-5:00pm
Exempt Status: Exempt
Location: Remote
Department name: SOM DOM Infectious Disease
Personnel area: School of Medicine

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 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.


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.

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

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. 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. 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 on 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.

Note: Job Postings are updated daily and remain online until filled.

Total Rewards
The referenced salary range is based on Johns Hopkins University’s good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. 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/.

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 atjhurecruitment@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 visithttps://accessibility.jhu.edu/.

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


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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