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Company

The Johns Hopkins University · 1 day ago

Research Program Manager - 116666

Baltimore, MD

Full-time

Remote

Mid, Senior Level

$56K/yr - $98K/yr

5+ years exp

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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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Pediatric TB expertiseClinical research practicesData analysisProtocol writingBilingual (English & Spanish)Grant writingStatistical knowledgeREDCapSTATAREndnoteMS WordMS ExcelSupervisory experienceTraining development