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The Department of Neurology is seeking a Research Navigator, sIRB Navigator who will support the Brain Injury Outcomes (BIOS) Division an academic research organization which manages multi-center, 20+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. 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
Research Navigator, sIRB Navigator will serve a critical role as liaison and facilitate meetings between project stakeholders and BIOS leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist coordinating center personnel in the auditing and monitoring of studies.
The Research Navigator, sIRB 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, sIRB Navigator will also be responsible for managing BIOS-investigator relationships.
The Research Navigator, sIRB 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, sIRB 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 to modernize, disseminate, renovate and remodel. This individual will serve as a knowledgeable liaison between BIOS leadership and the CTSA communities and other consortiums.
This position reports to the BIOS Faculty and leadership.
Specific Duties & Responsibilities:
- Work with site investigators to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements).
- Execute project management processes and methodologies to ensure projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the investigative teams by ensuring smooth implementation of new trials from conception through study activation.
- Prepare regulatory documents for single (sIRB) review for studies seeking sIRB coordination resources.
- 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 sIRB.
- Assist the JHM IRB in contacting participating sites to address inquiries related to IRB review.
- Train participating site leads on sIRB expectations/procedures.
- Coordinate with JHM sIRB leads to enhance sIRB processes for BIOS-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.
- Draft consents.
- 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 institutions.
Minimum Qualifications (Mandatory):
- Bachelor’s Degree with course work in science or health care administration required.
- Minimum of 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, and delivering effective research project management solutions.
- Additional education may be substituted for required 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.
* 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.
- Master’s Degree preferred.
- Certification as a Clinical Research Professional strongly preferred
Special Knowledge, Skills & Abilities:
- 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.
- Experience with local and/or single IRB policies and submissions.
- Must be proficient in Microsoft Office and 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.
- 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.