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The Johns Hopkins School of Medicine, Pediatrics Infectious Disease seeks an experienced Research Program Manager to work closely with divisional Principal Investigators in Research activities relating to mentoring new research staff in fulfillment of job duties and supporting faculty in clinical research efforts. These activities will facilitate: (i) the efficient completion of funded research; (ii) the initiation of industry-initiated trials which will generate revenue for the Department while promoting the academic productivity of faculty; (iii) the completion of study-related tasks for unfunded faculty in pursuit of pilot data for grant applications; (iv) completion of data collection for faculty between grants which will allow for continued productivity and successful future grant applications.
This person will report directly to Dr. Nicole Salazar-Austin (PI) with a dotted line to SMILE-TB Research Nurse Manager in the Division of Pediatric Infectious Disease. 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).
Project summary
The U.S. State Department launched the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) project. The SMART4TB mandate is to identify more effective methods and tools for finding, treating, and preventing 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 and new treatment drugs and regimens. Led by Johns Hopkins University School of Medicine, the SMART4TB international consortium partners includes the University of California, San Francisco, KNCV Tuberculosis Foundation and Elizabeth Glaser Pediatric AIDS Foundation.
Specific Duties and Responsibilities
- Assist investigators in implementation and monitoring of clinical research protocols. This may include,
- Review clinical aspects of adverse events and provide guidance on clinical management of children diagnosed with drug-susceptible TB and children living with HIV across multiple international research sites.
- Develop and provide trainings on pediatric TB for site clinicians, staff and recruiting clinic staff to assist with recruitment and enrollment as indicated.
- 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.
- Coordinate training of study teams on eIRB and CRMS systems.
- Preparation and submission of protocols for submission to the JH School of Medicine Institutional Review Board (or similar IRB) including the management of ongoing submissions (i.e. change in research requests, continuing review reports, adverse events, significant adverse events). Stay informed of IRB protocol changes and general updates. Troubleshoot IRB communications problems. Keep track of all study approval dates and timelines for required communication to IRB.
- 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.
- Provide pediatric TB clinical expertise as member of the SMILE-TB Clinical Management Committees (CMC) and attend monthly CMC meetings.
- Collaborate with Data Manager to oversee operational oversight of the SMILE-TB Clinical Data and Endpoint Review Committee.
- Monitors data quality and accuracy as required by research protocol. Will run pre-established queries and may develop ad-hoc queries/reports as requested Utilizing working knowledge of study(s) will participate in meetings to provide operational updates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues.
- Assist with U.S. State Department 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.
- 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 and pediatric HIV in low resource settings
- 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
Minimum Qualifications
- Bachelor's Degree in a related field.
- Five years of related experience in clinical research in an academic,
- Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Preferred to also have Master’s or Doctoral degree in epidemiology, public health or other research-related field.
- Extensive experience with STATA and/or R, REDCap, Endnote, MS Word and MS Excel.
- Extensive experience with protocol and informed consent writing and data analysis.
- Extensive experience with clinical research sciences.
- Must have a strong background in research methods and participant recruitment.
- Minimum of three (3) year hands-on patient care experience in a hospital setting providing patient care.
- Knowledge of clinical research practices and principles required.
- Experience with data analysis strongly preferred.
- Experience with manuscript, grant and/or protocol writing strongly preferred.
- Knowledge of basic statistics strongly preferred.
Classified Title: Clinical Research Manager
Job Posting Title (Working Title): Research Program Manager (SOM Pediatric Infectious Diseases)
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($68,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F; 8 - 5pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Ped Infectious Disease
Personnel area: School of Medicine
