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The Johns Hopkins School of Medicine seeks an experienced Research Program Manager to work closely with Department of Pediatrics Infectious Diseases Principal Investigator (PI) in activities relating to mentoring and supporting initiation of clinical research in high burden TB countries. This person will report directly to Dr. Nicole Salazar-Austin (PI) with a dotted line to two Senior Research Nurses in the Division of Infectious Disease at the Johns Hopkins School of Medicine. The Research Program Manager will closely coordinate with research teams at all TA2 research sites. The portfolio will include complex TB and HIV clinical research studies being implemented in partnership with academic institutions at each study site, with a primary focus of supporting the SMILE-TB and PRISM-Kids portfolios. This person would be a critical member of a fast-paced international team of researchers, administrative staff, and study coordinators.

Under limited supervision, this role supports PI research programs and/or clinical trials by coordinating protocol implementation and monitoring the collection of data for studies. The range of duties includes but is not limited to tracking participant recruitment/interviews at multiple international sites for multiple studies, data collection, organizing collected information; records management, and communicating with team members on the status of project(s).

Program Manager, oversees and evaluates the performance of undergraduate and graduate research assistants supervises and observes and assesses work, provides feedback, trains and performs evaluations.

This role utilizes pediatric TB clinical expertise alongside knowledge of theory and statistics and applies these skills to the administration of the scientific protocol and assigned projects.

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 cooperative agreement, to identify more effective methods and tools for finding, treating, and preventing tuberculosis (TB) in 24priority 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. Led by Johns Hopkins University School of Medicine, theSMART4TB international consortium partners are University of California, San Francisco, KNCV Tuberculosis Foundation, Elizabeth Glaser Pediatric AIDS Foundation, Treatment Action Group, Perinatal HIV Research Unit (South Africa), YR Gaitonde Medical, Educational and Research Foundation (India), Walimu (Uganda), Kyrgyz State Medical Academy, and Victory Network (Vietnam).

Specific Duties and Responsibilities

• Assist investigators in development and implementation of clinical research protocols. 
  
• Develop and provide trainings on diagnosis of pediatric TB for site clinicians, staff and recruiting clinic staff to assist with recruitment and enrollment.
  
• Review clinical aspects of adverse events and provide guidance on clinical management of children diagnosed with drug-susceptible and drug-resistant TB across multiple TB studies and international research sites.
• Assist with site training and study implementation in Spanish-speaking countries.

• Travel to international research sites across USAID high TB priority countries.
  
• Provide pediatric TB clinical expertise as member of the SMILE-TB and PRISM-Kids Clinical Management Committees (CMC) and attend monthly CMC meetings.
  
• Conduct independent literature searches and locate references for research projects and manage them in Endnote.
  
• Supervision of undergraduate and graduate student research assistants.
  
• Monitors data quality and accuracy as required by research protocol. Will run pre-established queries and may develop ad-hoc queries/reports as requested.
  
• Assist data analysis team with clinical understanding of adverse events in children diagnosed with drug-susceptible and drug-resistant TB and other data interpretation needs.
  
• Prepare of grant proposals and manuscripts (template and word processing aspects).
  
• Assist with manuscript writing and submission.
  
• Assist in preparation and submission of protocols to the JH School of Medicine Institutional Review Board (or similar IRB) including management of ongoing submissions (i.e. change in research requests, continuing review reports, adverse events, significant adverse events).
  
• Prepare dissemination materials (ppts, documents, reports) for relevant agencies (e.g. funders, IRB, scientific team, key stakeholders, community advisory board/s) and other forums for dissemination of interim or final study results.
  
• Assist with USAID reporting and work plan development.
  
• Utilizing working knowledge of study(s), participate in meetings to provide operational updates, report on any operational issues, and make recommendations for resolutions to new/outstanding operational issues when indicated.
  
• May assist in coordinating study(s) meetings, which may include assisting in developing an agenda and coordinating information and/or participation of individuals from other institutions and/or universities.
  
• Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to multiple clinical trials.
  
• Assist with tracking and reporting milestones for financial invoicing.
  
• Where helpful, take study meeting minutes and develop and track action steps (particularly in the Clinical Monitoring Committee meetings where medical background is needed)
  
• Attend protocol team, clinical research site team meetings and other study related meetings when indicated.
• Other duties as assigned.
  

**Willingness and ability to travel to international research sites across USAID high TB priority countries

Special Knowledge, Skills, or Abilities/Competencies

• Experience in diagnosis and/or treatment of pediatric TB in low resource settings.
  
• Minimum of three (3) year hands-on patient care experience in a hospital setting providing patient care.
  
• Excellent organizational skills required.
  
• Excellent attention to detail skills required.
  
• Ability to manage multiple and competing priorities.
  
• Must have excellent time management skills.
  
• Ability to work in a team and demonstrated interpersonal skills.
  
• Knowledge of clinical research practices and principles required.
  
• Experience with data analysis.
  
• Experience with manuscript, grant and/or protocol writing.
  
• Bilingual in English & Spanish.
  
• Knowledge of basic statistics.

• Bachelor's Degree in related discipline. Related Master's preferred.
• Five years related experience, including demonstrated supervisory or lead responsibilities.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Preferred to also have Master’s or Doctoral degree in epidemiology, public health or other research-related field.
• Must have a strong background in research methods and participant recruitment.
• Extensive experience with clinical research sciences.
• Extensive experience with protocol and informed consent writing and data analysis.
• Extensive experience with STATA and/or R, REDCap, Endnote, MS Word and MS Excel.
• Demonstrated leadership ability, supervisory experience preferred.

Classified Title: Research Program Manager 
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $55,800 - $97,600 Annually ($67,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F: 8:30 - 5 
Exempt Status: Exempt 
Location: Remote 
Department name: SOM Ped Infectious Disease  
Personnel area: School of Medicine