The Johns Hopkins University · 11 hours ago
IRB Analyst - 116466
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Responsibilities
Provide pre-review for incoming IRB research applications, determine adequacy of IRB applications and level of review required, select reviewers for protocol reviews, follow-up with IRB reviewers to assure appropriate level of review provided, and prepare post-approval letters and finalized documents through eHIRB.
Provide guidance to research team members regarding the IRB submission process and assist researchers with the development of an IRB application and/or informed consent documents.
Support and document all IRB meetings with agendas, meeting minutes, and other relevant materials.
Perform quality assurance reviews to ensure compliance with IRB policies and federal regulations, including assisting with audits, protocol and informed consent review, and recordkeeping review.
Provide education and training and act as internal consultant to staff, IRB committee members, and the JHU research community.
Assist in revising IRB and human subject research policies and procedures.
Conduct testing of the electronic HIRB system to identify problems and bugs, reporting issues via Jira where identified.
Occasionally assist with updating the IRB website.
Perform routine database queries and report generation, including a monthly expedited report.
Monitor the Office’s general HIRB email inbox and respond to requests for information, complaints, and concerns.
Support the Homewood Conflict of Interest and Commitment Program, on as needed basis.
Other duties as assigned.
Qualification
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Required
Proficiency with Microsoft Office Suite and Outlook required.
Working knowledge of the federal regulations related to IRB and human subject research subjects.
High level of organizational skills and time management and strong analytical reasoning skills.
Can work with limited supervision, makes decisions and establishes work priorities on essentially procedure-oriented operations.
Must be service-oriented and able to interact effectively with individuals at all levels of the organization.
Excellent written and oral communication skills.
Ability to maintain a high level of confidentiality.
Bachelor's Degree.
Three years of related human subjects compliance and/or research administrative experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Preferred
Three years of IRB regulatory experience, preferably in an academic setting.
Certified IRB Professional (CIP) credential.
Familiarity with WordPress.
Company
The Johns Hopkins University
Johns Hopkins University is a research university that enrolls full and part-time students throughout nine academic divisions.
Funding
Current Stage
Late StageTotal Funding
$207.4MKey Investors
Advanced Research Projects Agency for HealthMaryland Stem Cell Research Fund (MSCRF)Alfred P. Sloan Foundation
2024-08-15Grant· $20.9M
2023-05-11Grant
2021-01-01Grant· $1.5M
Recent News
2024-12-06
2024-11-25
Alfred P. Sloan Foundation
2023-10-26
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