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Email Verified Sarah L
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Member since August 13, 2021
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Clinical Research Professional

Experienced clinical research professional with a Master of Bioscience focused in Clinical and Regulatory Affairs and demonstrated history of working in the both medical device and pharmaceutical industries. Therapeutic areas include CNS/neurology, cardiology, urology, ophthalmology, oncology, and pediatrics.

Specialties:

  • Quality management of Clinical Vendors including CROs, Core Labs, Contract monitors, physician consultants, etc.
  • Clinical trial planning, execution, and monitoring
  • Developing Clinical Strategy and Evaluation Plans
  • Pre-clinical study design, planning, and execution
  • Interpreting and implementation of US 21 CFRs, ISO, EU MDD, and AU TGA requirements
  • Application of GMP, GLP, and GCP
  • Protecting the rights, welfare, and safety of Research subjects

Experience

Principal Consultant

  •  Ology Univesal Research Solutions
  •  Aug 2015 - Present

Instructor

  •  University of California, Irvine
  •  Nov 2016 - Present

Courses taught:
• Post-Approval Compliance Requirements for Pharmaceutical Products
• Regulatory Affairs for Post-Market Approval
• Regulatory Affairs Planning and Management: Concept Review and Evaluation
• Overview of Global Regulatory Affairs

Sr. Clinical Trial Management Associate

  •  Allergan
  •  Jun 2019 - Dec 2019

Sr. Clinical Research Associate

  •  Urovant Sciences
  •  Nov 2018 - Apr 2019

Sr. Clinical Trial Management Associate

  •  Allergan
  •  Aug 2016 - Nov 2018

Clinical Research Associate

  •  Endologix
  •  Feb 2020 - Feb 2016

Clinical Research Associate

  •  Ivantis
  •  Jan 2013 - Jan 2015

Clinical Trial Associate

  •  Clinipace Worldwide (Formerly Paragon Biomedical)
  •  Feb 2012 - Jan 2013

Education

Masters of Biomedical Sciences

  •  Keck Graduate Institute
  •  Aug 2013 - May 2015

Graduate Certificate, Clinical Trials: Medical Device and Drug Development

  •  University of California, Irvine - Division of Continued Education
  •  Nov 2010 - May 2012

BA in Biology / Minor in Chemistry

  •  Xavier University of Louisiana
  •  Aug 2003 - Dec 2007