The Research Navigator 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 translational clinical protocols that will yield important new information in a timely fashion. The Research Navigator is responsible for working with multiple (up to 40) research teams to help translate their research into clinical protocols. Research Navigator support will be available at all stages of the project, from pre-clinical investigations and testing, through running, concluding, analyzing, and disseminating the data from the clinical study. 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 institutional level, will be more efficiently addressed with the assistance of the Research Navigator, who will work with designated liaisons in Hopkins research support offices such as Office of Research Administration, Office of Human Subjects Protection, Office of Research Billing and the Technology Transfer Office. Research Navigators will further help to stream line the protocol approval process by working with research teams to develop timelines and optimize strategies for coordinating efforts between the various regulatory and administrative offices. Research Navigators will have a thorough knowledge and understanding of all programs and resources within the ICTR and CTSA that are available to assist research teams. This knowledge will enable the Research Navigator to function as a liaison for inquiries related to receiving ICTR and CTSA support. In addition, Research Navigators will work with ICTR leadership to identify any problems and implement any initiatives which will help to ensure that research support from the various ICTR 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 Navigators will have a direct reporting relationship to Dr. Carol Kobrin, Director of the Institute for Clinical and Translational Research (ICTR) Research Studio, and indirect reporting relationships to Dr. Daniel Ford, Director of the ICTR, and Roxanne Stambaugh, the Administrative Manager of the ICTR.
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 and external regulatory agencies (e.g. FDA, RAC.) As appropriate, facilitate communication between PIs and common entities associated with research (e.g. NIH). Utilize a thorough knowledge of policies and procedures for approval and implementation of protocols to ensure work moves as quickly as possible through the system and to study completion.
Assist the study team and collaborate with them to manage complex clinical studies which may require a broad scope of scientific, medical and regulatory knowledge, superior organizational skills, and exemplary analytical and data extraction abilities.
Consult and advise teams regarding preparation and maintenance of IRB and other institutional, regulatory documentation required for clinical and basic research projects.
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.
Consult and advise teams regarding preparation of documentation for outside auditors, corporate sponsors, or federal regulatory agencies like OHRP, the FDA, or NIH.
Assist investigators in the development of standard operating procedures.
Maintain a detailed knowledge and understanding of the portfolio of all assigned protocols to be able to quickly consult with investigators on issues and/or problems.
Assist investigators in writing clinical protocols, and in defining information and plans required to accomplish study goals.
As appropriate, will introduce the investigator to other resources or individuals within JHU who can assist with any question that cannot be addressed by the study team.
In conjunction with the JHM ORA/CRSS, advise Principal Investigators/Study Teams on patient/procedure billing issues and hospital/university guidelines regarding billing.
Regularly review with Principal Investigator and Research Coordinators overall study progress for all projects receiving ICTR funding and other projects as required by ICTR leadership.
Discusses potential problems with investigators and suggests possible solutions.
Assist in planning and implementing solutions as required.
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).
Is knowledgeable of institutional and federal biosafety requirements for human research.
Develop efficient and effective work flow processes.
Assist JHMI faculty and staff in finding training for the various network processes and procedures used to conduct clinical research at JHMI (e.g. eIRB, EPIC).
Prepare annual and quarterly progress reports as directed by the ICTR Studio Director.
Assist ICTR leadership with development of methods evaluating:
Which types of studies benefit the most from the services of a Navigator whether or not the ATIP funding program is providing a useful service to investigators.
If the Research Studio is fulfilling its intended purpose of a coordinated, multidisciplinary service center with a goal of facilitating clinical and translational research.
Work with ICTR Deputy Directors, Translational Core Directors, and other designated members of ICTR leadership, to operate the ICTR Research Studio. Responsibilities for operating the studio include:
Organizing pre-Studio consultations with research teams to define research questions and identifying areas requiring assistance for further development.
Based on the pre-Studio consultation, conferring with Studio Director and an ICTR Deputy Director to decide which issues require a Studio consultation and which can be handled by referral to the appropriate resource.
Prepare for a Studio 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 Studio consultation by launching the meeting with a structured discussion of the proposed study and managing time usage.
Following the Studio consultation, create a written summary of the proceedings and follow-up with the investigator to get their feedback about the usefulness of the consultation.
Support the ICTR Translational Research Communities with their comprehensive knowledge of translational clinical research.
Each TRC will be assigned a Navigator who will be responsible for:
Familiarizing themselves with the subject area and translational pathways being discussed by the TR.
Helping to address questions throughout the life cycle of a translational project (i.e. from pre-clinical investigations through concluding a clinical study) providing regulatory and project management support for all TRC directed ATIP pilot projects.
Assist with the 3 phases of the ATIP funding program:
Phase 1, submission of new ATIP applications and 2 rounds of review to identify awardees. Navigators will:
Perform Triage Review prior to forwarding to faculty reviewers to assess compliance with budgetary, content, eligibility and other submission guidelines
Organize meetings for Reviewing Rounds 1 and 2, including securing both internal and external reviewers
Perform feasibility assessments of second round applications including a plan for securing all applicable regulatory approvals and agreements for required collaborations
Provide "feasibility assessments” to the ATIP Advisory Group for Final Review.
Phase 2 of the ATIP funding program, investigators are awarded their grants. Navigators will function as the project manager for the lifetime of the grant and report progress back to the ATIP Advisory group on whether or not project milestones are being met on a quarterly schedule.
Phase 3 of the ATIP funding program, after the grant concludes. Navigators will maintain contact with former ATIP awardees through surveys and interviews to track project development as requested by ICTR leadership.
Navigators are also responsible for the coordinating all components of the ATIP program, that require linkage to other entities such as the ICTR Studio and Studio experts, Cores, appropriate regulatory offices, etc.
Bachelor’s Degree required.
Five (5) years’ 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.
Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.
Certification as a Clinical Research Professional is strongly preferred and certification by the Regulatory Affairs Professionals Society is desirable.
Master’s degree preferred.
Preferred experience in 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).
Must adhere to policies related to protecting and reporting of sensitive and confidential patient information.
Must 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 37.5/E/04/ME
Starting Salary Range: $60,945 – $83,865 (commensurate with experience)
Location: 750 E. Pratt Street Baltimore, MD – East Baltimore
Department name: 10003311-SOM ICTR Inst Clin Translational Resrch
Personnel area (School): SOM – School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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