Research Program Manager (DOM Infectious Disease)

Research Program Manager (DOM Infectious Disease)

The Division of Infectious Diseases is seeking a Research Program Manager who will oversee programmatic and administrative aspects of the Rapid Acceleration of Diagnostics Program funded through the NIH in the Center for Innovative Diagnostics for Infectious Diseases (CIDI). The job will require understanding of and experience with reference laboratory assays, point-of-care devices, and interface with both the sponsor and medical technology device companies to accelerate development toward FDA clearance. This position is responsible for all company-facing liaison activities. This includes; initial contact meetings (scheduling, executing non-disclosure agreement for initial meeting, follow-up of action items); linking companies to CIDI resources under materials transfer agreements, data use agreements, protocols, and regulatory compliance; SBIR application requests; annual solicitation oversight with follow-up of the 3-6 companies that get awards matching progress to pre-specified milestones and timelines; annual CIDI showcase event planning, resource mobilization and maintain CIDI website. All of these activities are to accelerate the development of point-of-care diagnostics for infectious diseases.

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Research Program Manager works under the general supervision of a PI to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration, and regulatory compliance. Supervise or oversee other exempt-level research staff; may oversee staff at local or multi-center sites.

Specific Duties & Responsibilities

• Partner with investigator(s) and exercise independent judgment in managing the conduct of the research on behalf of the PI.
• Participate in scientific discussions with collaborators, PIs, and funding organizations.
• Collaborate with PI 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.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• Demonstrated supervisory or lead responsibilities.

Preferred Qualifications

• Master's Degree in a related field.
• Certification as a Clinical Research Professional.