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Regulatory Affairs Specialist Abramson Cancer Center (Remote Eligible)
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- Regulatory Affairs Specialist (Abramson Cancer Center)(Remote Eligible)
- The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Specialist to participate in the coordination of Phase I-V clinical trials.
- Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
- The Regulatory Affairs Specialist is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits.
- The Regulatory Affairs Specialist is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials.
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