Research Navigator

The Department of Neurology is seeking a Research Navigator for the BIOS CCTC (Clinical Trials Coordinator Center). This position will support the innovative work of BIOS CTCC as a member of the BIOS Consultation and Grant Production Team. BIOS manages multi-center, 30+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. BIOS, which is also an NIH (National Institutes of Health) funded JHU Trials Innovation Center (TIC), incorporates the TIC, as part of the NIH Trial Innovation Network (TIN) initiative to address roadblocks in clinical trials and accelerating the translation of novel interventions into life-saving therapies. BIOS also supports the Johns Hopkins Institute for Clinical and Translational Research (ICTR), an NIH funded Clinical and Translational Science Awards (CTSA) facilitate their Trial Advisory Program (TAP) focusing on the development of investigative expertise, such as, K-grant, T-grant, and other early career investigators. in addition, BIOS, as an academic research organization (ARO), collaborates with investigators from academia, pharmaceutical, and commercial entities independent of the TIC/TAP programs to help facilitate novel ideas into funded trials and study implantation. The research Navigator will support the consultation and grant production (consult/grant) work of the TIC, TAP, and BIOS ARO mechanisms.

The Research Navigator will work with investigators in project evaluation, trial simulation, and planning activities. In this position, there are opportunities to work with a high functioning, cutting edge team that will study, understand, and improve multi-site translational research. This position requires a person with clinical trial design expertise and regulatory experience in working with IRBs, master/standard agreements and various grant mechanisms and funding agencies. Autonomy, creativity, and critical thinking skills are strongly encouraged and welcomed.

The Research Navigator will have or develop a thorough knowledge and understanding of all programs and resources within the consult/grant mechanisms available to assist research teams. This knowledge will enable the Research Navigator to function as a liaison for inquiries related to receiving consult/grant support. In addition, the Research Navigator will work with BIOS/TIC/TAP leadership to identify any problems and implement any initiatives that will help to ensure that research support from the various consult/grant programs is provided in a timely and useful fashion to investigators. The Research Navigator is a highly motivated individual, who is comfortable working on multiple projects and is equally effective working independently or with a team.

The Research Navigator is an integral member of the BIOS consultation and grant production team, working closely with this team to ensure site investigators meet their targets and milestones for timely and accurate consultations, submission to proposed funding opportunities, or TIN/CTSA services. The Research Navigator will have a direct reporting relationship to the JHU TIC/TIN leadership and primary responsibility for the day-to-day operations of consult/grant work.

The Research Navigator will be responsible for all aspects of the protocol optimization process: assembling project plans, team, 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 will also be responsible for managing investigator relationships. The Research Navigator will assist or serve as the Consultation Lead to determine with investigators the priority discussion topics to be addressed during the consultation and organize the panel of expert consultants specially selected to accommodate the specific needs of each project.

The Research Navigator will be responsible for tracking consultations and resulting documentation through signature/approval processes then through dissemination to the TIN, TAP, and BIOS leadership. The Research Navigator will execute project management processes and methodologies to ensure consultations are completed on time, adhere to high quality standards, and benefit the investigative teams by ensuring a well-prepared grant application or smooth implementation of consult/grant services.

The Research Navigator will serve a critical role as liaison and facilitate meetings between project stakeholders and BIOS/TIC/TAP leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs (Standard Operating Procedures) as needed, assist in the auditing and monitoring of established workflows and processes. Building and maintaining strong, trusting relationships are critical.

The successful candidate will have experience presenting to investigative teams, end-users (faculty and staff), and subject-matter experts and must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills and exhibit a strong helpline orientation. The successful candidate will be expected to stay current with constantly changing clinical research technology and embrace the adoption of innovations for which the TIC/TAP is charged to modernize, disseminate, renovate, and remodel. This individual will serve as a knowledgeable liaison between the TIC/TAP 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 all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data during the consultation and grant production processes.

Ability to make independent judgments and act on decisions daily. Ability to work for extended periods of time without direction. Ability to prioritize own work and work of others as needed. Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines. Very strong organizational skills, analytical and problem-solving abilities, and attention to detail. Demonstrated ability to coordinate projects independently and work constructively as part of a team. Will oversee and coordinate the work of teams in other institutions. Ability to maintain confidentiality. Strong interpersonal and communication skills, both oral and written

Specific Duties & Responsibilities

• Support investigators by varying the level of assistance offered to satisfy their specific needs. The spectrum of support can range from general assistance to more customized help and collaborative interaction.
  

• Liaison between PIs (Principal Investigators), Research Nurses, Study Coordinators, research support/approval offices at JHMI, TIC/TIN, CTSA, BIOS personnel, and external regulatory and funding agencies (e.g., FDA, NIH, PCORI). Utilize a thorough knowledge of policies and procedures for the consultation to ensure work moves as quickly as possible through the protocol optimization process.
  

• Consult and advise teams regarding preparation and maintenance of IND/IDE and other regulatory documentation for external agencies, which are required for clinical research utilizing investigational agents.
  

• Maintain a detailed knowledge and understanding of the portfolio of all assigned proposals to be able to quickly consult with investigators on issues and/or problems.
  

• Assist investigators in designing clinical protocols, and in defining information and plans required to accomplish study goals. Coordinate discussions between the investigator and expert consultants assisting with any question that cannot be addressed by the study team.
• Develop efficient and effective workflow processes.
  

Assist the TIC/TAP/BIOS leadership with development of methods evaluating.

• Which types of studies benefit the most from the services of the appropriate consult/grant mechanism.
  
• Whether or not the consult/grant process is providing a useful service to investigators.
  
• If the consult/grant process is fulfilling its intended purpose of a coordinated, multidisciplinary service center with a goal of facilitating the development of clinical research.

Oversee all operational aspects of BIOS (including TAP/TIN) consultation and grant production.

• Defining operational policies and procedures that are aligned with overall BIOS consultation and grant production policies and procedures.
  
• All pre-consultation communications with investigators about the administrative aspects of their consultation and all matters related to addressing their research questions and identifying areas requiring assistance for further development.
  
• Based on the pre-consultation discussion, conferring with BIOS consultation and grant production personnel to decide which issues require a consultation and which can be handled by referral to the appropriate resource.
  
• Prepare for a consultation by ensuring the meeting is scheduled, all the reviewers have been invited and acknowledge their agreement to participate, and distributing to the reviewers all necessary background material.
  
• Run the actual consultation by launching the meeting with a structured discussion of the proposed study and managing time usage.
  
• Following the consultation, create a written summary of the proceedings and follow-up with the investigator to get their feedback about the usefulness of the consultation.
  
• Seek out and implement ways to tightly integrate these programs into the larger TIC/TAP/JHU organization and to connect these programs with other TIN/CTSA initiatives.
  
• Implement strategic direction as set by the TIC/TAP/BIOS leadership.
  
• Advise the TIC/TAP/BIOS leadership on program activities, needs, obstacles, and progress on a weekly schedule.
  
• Supervise the consultation tasks (such as scheduling support, note taking, etc.) of one or more research navigators and advise the TIC/TAP/BIOS leadership regarding areas of need, hiring, and personnel/performance/workload management.
  
• Support the work of the TIC/TIN, TAP, BIOS, and CTSA in data collection and measurement of program-associated metrics.
  
• Produce quarterly reports and an annual report on program progress, including qualitative and quantitative data, anecdotal reports of successes, analysis of areas of need or obstacles, and opportunities for growth and present to TIC/TAP/BIOS/CTSA leadership.
  
• Collaborate with stakeholders during consultation to produce deliverables necessary for grant production.
  

• Oversee grant production activities as defined by target funding announcement and internal SOP.
  

• Collaborate with other TICs, CTSAs, collaborators, and partners.
  

• This position reports to the BIOS leadership and TAP/TIC Faculty.

Additional Knowledge, Skills & Abilities

• Experience with local and/or single IRB policies and submissions.
  
• Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
  
• Proficient with SharePoint, collaborating and co-authoring of documents.
  
• Possess the ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.
  
• Is knowledgeable of and complies with current Good Clinical Practice Guidelines; applicable ICH Guidelines and FDA Guidance Documents; NIH and IRB requirements as well as Federal Regulations pertaining to research (e.g., FDA, OHRP).

• Requires Bachelor's Degree with course work in science or health care administration required. Certification as a Clinical Research Professional strongly preferred. Master's degree preferred.
• Requires a minimum of five year's experience in clinical trials/ medical research comparable to overseeing the administrative and scientific implementation of research protocol(s) for complex and/or multiple research studies. Within Hopkins environment, this could be equivalent to five years of experience working as a Sr. Research Program Coordinator II or Research Program Manager, for instance. Experience in clinical research at an academic, government, or pharmaceutical industry environment preferred.
• Additional education may substitute for experience to the extent permitted by the JHU equivalency formula

• Master's Degree preferred.
• Experience with REDCap preferred.

Classified Title: Research Navigator
Role/Level/Range: ACRP/04/ME
Starting Salary Range: $64,000 - $112,200 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status:Exempt
Location:Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine