This is an exciting opportunity to serve as a Research Navigator for the NIH funded JHU Trials Innovation Center (TIC). The TIC is part of an initiative to create the Trial Innovation Network as part of the Clinical and Translational Science Award (CTSA) Program. 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 and master/standard agreements. Autonomy, creativity, and critical thinking skills are strongly encouraged and definitely welcomed.
Specific duties & responsibilities:
The Research Navigator will work with CTSA site investigators to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements). The Research Navigator will execute project management processes and methodologies to ensure TIC projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the CTSA investigative teams by ensuring smooth implementation of new trials from conception through study activation. Specific activities include:
Prepare regulatory documents for CIRB review for studies seeking Level 1 TIC services.
Work with participating sites to compile local context information for initial review, continuing review, protocol event reports and applicable changes in research to facilitate submission to the JHM CIRB
Assist the JHM IRB in contacting participating sites to address inquiries related to IRB review
Train Hub liaisons and participating site leads on CIRB expectations/procedures
Coordinate with JHM CIRB leads to enhance CIRB processes for TIC-supported studies
Develop work plans to achieve assigned project goals and organize all activities in support of project goals
Complete and maintain professional documentation for projects and deliverables
Obtain all required documents for new grant and protocol submissions
Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delays in the approval process
Use professional judgment in handling information based on the situation and be sensitive to individual and organizational concerns
Ensure smooth implementation of new trials from conception through study activation
Work closely with the Studio Teams and Cores to ensure all documents are complete prior to study/trial activation
Develop SOPs as needed
Collaborate with other TICs
The Research Navigator will be responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
The Research Navigator will serve a critical role as liaison and facilitate meetings between project stakeholders and TIC leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist the RIC personnel in the auditing and monitoring of studies.
The Research Navigator will be responsible for 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 TIC-investigator relationships.
Minimum qualifications (mandatory):
Bachelor degree required.
Minimum of five (5) years’ experience in delivering effective project management solutions.
Master’s degree preferred, and may substitute for some experience, to the extent permitted by the JHU equivalency formula.
Knowledge of FDA, ICH, and other regulatory guidelines, experience in writing research materials, excellent leadership skills, as well as excellent interpersonal and communication skills are also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs such as electronic data capture software, and project management software, which will be taught on the job.
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.
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 a constantly changing clinical research technology and embrace the adoption of innovations for which the TIC is charged to modernize, disseminate, renovate and remodel. This individual will serve as a knowledgeable liaison between the TIC leadership and the CTSA 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.
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
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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