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Inside Higher Ed · 4 days ago

Research Program Manager (DOM Infectious Disease)

Baltimore, MD

Full-time

Hybrid

Senior Level

$56K/yr - $98K/yr

5+ years exp

Johns Hopkins University is seeking a Research Program Manager for the Division of Infectious Diseases to oversee programmatic and administrative aspects of the Rapid Acceleration of Diagnostics Program. The role involves managing clinical protocols, collaborating with faculty, and ensuring regulatory compliance while supervising research staff.

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Responsibilities

Partner with investigator(s) and exercise independent judgment in managing the conduct of the research on behalf of the Pl

Participate in scientific discussions with collaborators, PIs, and funding organizations

Collaborate with Pl to ensure operational feasibility of proposed protocol/study design

Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s)

Develop or oversee the development of consent form(s) for clinical trials based on protocol(s)

Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the PI

Train and provide oversight of research data management and regulatory issues

Work with commercial and/or government agency sponsors to determine which group can commit to considering patient population, available resources, and cost of providing services

Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget

Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and processes/systems are in place to ensure the PRA is followed when required

Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing

Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials

Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data

Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial

Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies

Contribute to presentations and manuscripts

Hire, supervise, and manage the performance of other exempt-level research staff

Other duties as assigned

Qualification

Clinical research managementRegulatory complianceProtocol developmentSupervisory experienceBudget developmentData managementCollaborationCommunication skillsProblem-solving