Reagan Byrum
Clinical Research Manager Regulatory Compliance at Sanford Research- Claim this Profile
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Bio
Experience
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Sanford Research
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United States
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Research Services
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1 - 100 Employee
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Clinical Research Manager Regulatory Compliance
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Jul 2022 - Present
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Supervisor- Clinical Research Regulatory Compliance Team
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Mar 2021 - Jul 2022
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Senior Clinical Research Compliance Specialist-
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Mar 2020 - Mar 2021
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Clinical Research Compliance Specialist
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Jul 2019 - Mar 2020
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Elanco
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Quality Assurance Associate
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2014 - Jun 2019
Compliance Specialist Raw Material, Antigen, and Final Batch Release. Quality Control Testing review and release. Lab Investigation,Deviation, and CAPA review and approval. Change Control assessments and approvals. SOP review and approval. QA approval of Assay improvement, Reference Stability, and other protocols and reports. Systems: SAP, Trackwise,SharePoint. Compliance Specialist Raw Material, Antigen, and Final Batch Release. Quality Control Testing review and release. Lab Investigation,Deviation, and CAPA review and approval. Change Control assessments and approvals. SOP review and approval. QA approval of Assay improvement, Reference Stability, and other protocols and reports. Systems: SAP, Trackwise,SharePoint.
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Quality Control
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2007 - 2014
Potency Testing Lead in the development and implementation of a Reference monitoring program. Assay improvement. SOP, protocol and report writing. Potency Testing Lead in the development and implementation of a Reference monitoring program. Assay improvement. SOP, protocol and report writing.
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Fort Dodge Animal Health
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Research And Development Scientist
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2001 - 2005
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Education
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South Dakota State University
Bachelor's degree, Microbiology, General