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Requisition ID:  117833

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 may be embedded in multicenter clinical trials.
  • Assist investigators in defining information and plans required to accomplish study goals.
  • Coordinate discussions between the investigator and consultants assisting with questions that cannot be addressed by the study team.
  • Support investigators by varying level of assistance offered to satisfy specific needs, support can range from general assistance to more customized help and collaborative interaction.
  • Liaison between PIs, Research Nurses, Study Coordinators, research support/approval offices at JHMI, TIC/TIN, CTSA, BIOS CTCC personnel, and internal/external regulatory agencies.
  • Utilize a thorough knowledge of policies and procedures for the consultation and trial implementation process to ensure work moves as quickly as possible through the consultation and trial implementation processes.
  • Consult and advise teams regarding preparation and maintenance of trial materials, training modules, trial cycle timelines. and regulatory documentation for external agencies required for clinical research utilizing investigational agents, treatments or observations.
  • Maintain a detailed knowledge and understanding of the portfolio of assigned proposals to be able to quickly consult with investigators on issues and/or problems.
  • Develop efficient and effective workflow processes.


Assist the TIC /BIOS CTCC leadership with development of evaluation methods

  • Determine types of trials that benefit from the services of the appropriate innovation mechanisms.
  • Determine whether secondary research projects and tested innovations are useful services to investigators.
  • Determine If the innovations unit is fulfilling its purpose of a coordinated, multidisciplinary service center facilitating the improvement of clinical research.


    Oversee operational aspects of BIOS CTCC and TIN Innovations Unit.

    • Define operational policies and procedures aligned with overall BIOS CTCC policies and procedures.
    • Communicate with investigators about the innovation aspects of their consultation and matters related to addressing their innovations questions and identifying areas requiring assistance for further development.
    • Confer with BIOS CTCC/TIC consultation and grant production teams to decide which issues require a consultation and which can be handled by referral to the appropriate resource.
    • Lead the Innovations Unit team to implement and study current innovation programs within trials that are operationalized as part of BIOS CTCC and TIC contracts and grants
    • Lead the TIN Innovations WG as the project lead managing meetings and work product of the working group.
    • Prepare for secondary research study consultations by ensuring meetings are coordinated with project managers and necessary background material is distributed to stakeholders.
    • Run secondary research study consultations by launching meetings with a structured discussion of the proposed secondary research studies and managing time usage.
    • Create a written summary of the proceedings and follow-up with the investigator to get feedback about the usefulness of the consultation.
    • Lead the Innovations Unit in operationalizing the research of conducting Site Assessment Surveys, Accelerated Start-Up cycles, Gamification, Performance Studios, Gems Metrics and other secondary research programs to be created and imbedded in trials in tandem with Site Navigators and Project Managers following decisions to implement secondary studies,
    • Seek out and implement ways to integrate secondary research programs into the larger CTCC/TIC/ JHU organization and connect these programs with other TIN/CTSA initiatives.
    • Implement strategic direction as set by the TIC/ BIOS CTCC leadership.
    • Advise the TIC/ BIOS CTCC leadership on program activities, needs, obstacles, and progress on a weekly schedule.
    • Supervise the innovation unit tasks, e.g. scheduling support, note taking, etc. of one or more research navigators, data managers, and research assistants and advise the TIC/BIOS CTCC leadership regarding areas of need, hiring, and personnel/performance/workload management.
    • Support the work of the TIC/TIN, BIOS CTCC, 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/ BIOS CTCC/CTSA leadership.
    • Collaborate with stakeholders during consultation to produce deliverables for grant production, trial implementation, and secondary research studies.
    • Oversee multicenter trial materials production and operationalization activities as defined by notice of grant awards and internal SOPs.
    • Manage the publications and oversee manuscript production for peer review of secondary research
    • Manage budgetary allocations and personnel effort with BIOS CTCC leadership.
    • Collaborate with other TICs, CTSAs, collaborators, and partners.


    Additional Knowledge, Skills & Abilities

    • Knowledge of translational science and, team science, multicenter clinical trial project management.
    • Experience presenting to investigative teams, end-users, and subject-matter experts.
    • Excellent negotiation, facilitation, consensus-building, and diplomacy skills.
    • Strong helpline orientation.
    • Experience with REDCap.
    • Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
    • Proficient with SharePoint, collaborating and co-authoring of documents.
    • Ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.
    • Knowledge of and compliance 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).
    • Comfortable working on multiple projects.
    • Effective working independently or with a team.
    • Able to build and maintain strong, trusting relationships.
    • Ability to make independent judgments and act on decisions.
    • Ability to prioritize own work and work of others.
    • Strong organizational skills, analytical and problem-solving abilities.


    Minimum Qualifications
    • Bachelor's Degree in related field.
    • Minimum of five years related experience in clinical trials/ medical research.
    • Prior oversight of administrative and scientific implementation of research protocol(s) for complex and/or multiple research studies. 
    • Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.


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

     

     

    Classified Title: Research Navigator 
    Role/Level/Range: ACRP/04/ME  
    Starting Salary Range: $64,600 - $113,300 Annually (Commensurate w/exp.) 
    Employee group: Full Time 
    Schedule: M-F 8:30 am - 5:00 pm 
    FLSA Status: Exempt 
    Location: Hybrid/School of Medicine Campus 
    Department name: SOM Neuro BIOS 
    Personnel area: School of Medicine 

     

     

    Total Rewards
    The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

    Education and Experience Equivalency
    Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

    Applicants Completing Studies
    Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

    Background Checks
    The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

    Diversity and Inclusion
    The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

    Equal Opportunity Employer
    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    EEO is the Law
    https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

    Accommodation Information
    If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

    Vaccine Requirements
    Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

    The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
    The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
    Hybrid: On-site 1-2 days a week

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