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IRB Regulatory Consultant, Us
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- The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies).
- The IRB Regulatory Consultant will work with investigators, study staff, local and Central Institutional Review Board, and the sponsor of the clinical trial to ensure that the studies are conducted in compliance with ICH GCP, the FDA, IRB, and other regulatory requirements.
- Submit and obtain the approvals for clinical trials from internal committees and the Institutional Review Board (IRB).
- Establish and maintain regulatory study files (electronic and Physical) to ensure that all essential regulatory documents are up to date, complete and in compliance with the requirement of ICH -GCP, IRB, the FDA, and other applicable regulations.
- Collect, complete, and submit initial protocol, amendments, revisions to Informed Consent Forms (ICFs), continuing reviews, non-compliance issues, and study close out reports to the central and local IRB, as applicable.
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