Research Navigator

The Department of Neurology is seeking a Research Navigator, Innovations Unit for the BIOS Clinical Trials Coordinator Center (CCTC) Innovations Unit. This position leads the innovative work of BIOS CTCC Innovations Unit and supports the work of the Trial Innovation Center (TIC) and the BIOS Consultation and Grant Production Team. BIOS manages $30+ million dollar federally funded multi-center clinical trials and multiple site-specific pharmaceutical sponsored trials. BIOS, an NIH funded TIC, incorporates the TIC, as part of the NIH Trial Innovation Network (TIN) initiative to address roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies. BIOS, as an Academic Research Organization (ARO), collaborates with investigators from academic, pharmaceutical, and commercial entities to facilitate novel ideas into funded trials and study implementation. The navigator will support the selection and implementation of team science and innovative practices in the form of consultation and grant production work and lead the selection and implementation of best team science practices and innovative secondary research studies into multicenter clinical trials as trials are operationalized under TIC, and BIOS CTCC ARO mechanisms.

The Research Navigator will work with investigators in project evaluation, trial simulation, and planning activities. The navigator will lead a high functioning, cutting edge team that will study, understand, and improve operationalizing multi-site translational research. The Research Navigator will apply a knowledge and understanding of programs and resources available within the CTCC to assist research teams. The Research Navigator will function as a liaison for inquiries related to Good Clinical Practice and CTCC support. Will work with BIOS CTCC/TIC leadership to identify problems and implement initiatives to ensure that timely and useful research support for innovation programs is provided to investigators. The Research Navigator works closely with the BIOS CTCC and TIC Innovation Unit production teams to ensure site investigators meet targets and milestones for implementations and operations, as well as performance analysis and publication opportunities. The Research Navigator reports to to the JHU TIC/TIN leadership and has primary responsibility for the day-to-day operations of CTCC and TIC innovations development and secondary research programs.

The Research Navigator will be responsible for all aspects of the innovations optimization process: assembling project plans, teams, and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately. The Research Navigator manages investigator relationships. The Research Navigator will assist or serve as a consultation lead to determine the priority of innovation topics to be addressed during the consultation and to organize the panel of expert consultants selected to accommodate the needs of each innovation project.

The Research Navigator will be responsible for tracking implemented innovations and resulting documentation through signature/approval processes and the dissemination to the TIN and BIOS CTCC leadership. The Research Navigator will execute project management processes and methodologies to ensure secondary research studies are completed on time, adhere to high quality standards, and benefit investigative teams by ensuring a well-prepared planning cycle and a smooth implementation. The Research Navigator will serve as liaison and facilitate meetings between project stakeholders and BIOS CTCC/TIC leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs, and assist in the auditing and monitoring of workflows and processes. The Research Navigator will stay current with changing clinical research technology and embrace the adoption of innovations for which the TIC is charged to modernize, disseminate, renovate, and remodel. This position will serve as a liaison between the TIC leadership and the TIN, CTSA, and Johns Hopkins communities. The Research Navigator will use professional judgment in handling information and be sensitive to project team, individual and organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making; help investigators develop insights and understanding of performance-based data during the consultation and grant production processes.

Specific Duties & Responsibilities

• Assist investigators in designing clinical protocols, trial plans, start-up activities, site vetting and selection, gamification, and other innovative randomized and nonrandomized secondary research projects that