The Johns Hopkins University – Tufts Medical Center Trial Innovation Center (JHU-Tufts TIC) Research Navigator, employed by the Johns Hopkins University Division of Brain Injury Outcomes (BIOS), will function as a comprehensive source of regulatory, administrative and project management information and assistance. The support provided by this position will be collectively applied to achieving well designed and efficiently run clinical protocols that will yield important new information in a timely fashion. The Research Navigator is responsible for working with multiple research teams to help translate their research into clinical protocols. To help ensure that research projects consistently and continuously maintain compliance with all applicable institutional requirements and regulations from external regulatory agencies, the Research Navigator must stay up to date with all current rules and be prepared to immediately report any changes to the research team. All questions that arise about the research at the Trial Innovation Network (TIN) level will be more efficiently addressed with the assistance of the Research Navigator, who will work with designated liaisons within the JHU-Tufts TIC, such as Office of Research Administration, Office of Human Subjects Protection, Office of Research Billing and the Technology Transfer Office and across the TIN. The Research Navigator will further help to streamline the consultation process by working with research teams to develop timelines and optimize strategies for coordinating discussion and efforts of consultants who are acknowledged authorities in their fields.
The Research Navigator will have a thorough knowledge and understanding of all programs and resources within the TIC, TIN, and CTSAs that are available to assist research teams. This knowledge will enable the Research Navigator to function as a liaison for inquiries related to receiving TIC, TIN, and CTSA support. In addition, the Research Navigator will work with TIC leadership to identify any problems and implement any initiatives that will help to ensure that research support from the various TIN 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 will have a direct reporting relationship to the JHU-Tufts TIC leadership and primary responsibility for the day-to-day operations of TIC consultations.
Specific duties & responsibilities:
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 TIN-integrated grant application or smooth implementation of TIN services.
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 leadership.
The Research Navigator will serve a critical role as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of established workflows and processes.
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 protocol optimization process.
Essential job functions:
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 a collaborative interaction.
Liaison between PIs, Research Nurses, Study Coordinators, research support/approval offices at JHMI, TIC/TIC/TIN personnel, and external regulatory and funding agencies (e.g. FDA, NIH). 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 within the JHU-Tufts TIC who can assist with any question that cannot be addressed by the study team.
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).
Develop efficient and effective work flow processes.
Assist the TIC leadership with development of methods evaluating:
Which types of studies benefit the most from the services of the TIC
Whether or not the TIC is providing a useful service to investigators
If the consultation process is fulfilling its intended purpose of a coordinated, multidisciplinary service center with a goal of facilitating the development of clinical research
The Research Navigator is responsible for all operational aspects of TIC consultations:
Defining operational policies and procedures that are aligned with overall TIN consultation 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 TIC 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 organization and to connect these programs with other TIN initiatives
Implement strategic direction as set by the TIC leadership
Advise the TIC 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 leadership regarding areas of need, hiring, and personnel/performance/workload management
Support the work of the TIC/TIN 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 leadership
Telecommuting for this position is permitted. Travel to the BIOS administrative offices in Baltimore, MD is required upon hire for training with required quarterly in person visits to Baltimore thereafter.
The successful candidate will be expected to operate independently, with guidance provided by TIC leadership. The candidate will have background and experience in research protection, federal and regulatory issues, research ethics, pharma law, pharmacovigilance, regulatory compliance, use of centralized IRBs and master agreements, and project management at the task level.
This position requires a high degree of independent action and adherence to strict timelines. Building and maintaining strong, trusting relationships is 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 a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel. This individual will serve as a knowledgeable liaison between the TIC leadership and the research communities.
Ability to make independent judgments and to act on decisions on a daily basis. Ability to work for long 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. This position reports to the TIC/BIOS leadership.
Bachelor degree in nursing or healthcare required. Advanced education may substitute for some years of experience.
Requires a minimum of five (5) years’ experience in delivering effective project management solutions and clinical trials/medical research comparable to overseeing the administrative and scientific implementation of research protocol(s) for complex and/or multiple research studies.
Project/system process lifecycle experience, including 2+ years of direct project management.
Excellent leadership skills with ability to negotiate and work collaboratively; service-oriented with excellent verbal and written communication and organization skills; knowledge of formal project management methodologies; experience in a higher education environment.
JHU Equivalency Formula:
18 graduate degree credits may substitute for one year of experience. 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.
Strong organizational skills
Manage multiple and competing priorities
Work independently as well as with various research teams
Effective interpersonal skills: must be an outgoing self-starter who can comfortably work with physicians and staff and get things done
Excellent time management skills
Attention to detail
Oral and written communication skills
Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
Master’s degree preferred. Advanced education may substitute for some years of experience.
Experience in clinical research at an academic, government, or pharmaceutical industry environment preferred.
Experience in the following areas is preferred: regulatory affairs, clinical trials, project management, and team-building.
Special knowledge, skills, and abilities:
Must have a working knowledge of federal regulations pertaining to clinical trials, research (FDA, OHRP), and good clinical research practices and principles (GCP). Adhere to policies related to protecting and reporting of sensitive and confidential patient information. Understand the importance and impact of data integrity in terms of patients, study results, costs, quality of service, and scientific research in general. Regular contact with physicians, other health care personnel requires the use of good judgment, tact, and sensitivity. This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Classified Title: Research Navigator Working Title: Research Navigator Role/Level/Range: ACRP/04/ME Starting Salary Range: $60,945-$83,865 (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003520-SOM Neuro BIOS Personnel area: School of Medicine
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