Work:
The Academy of Good Clinical Practice
Jan 2019 - Oct 2019
Clinical Quality Assurance Sme Consultant and Instructor
Sarepta Therapeutics
Jan 2019 - Oct 2019
Senior Clinical Trial Manager, Global Clinical Operations
Sarepta Therapeutics
Apr 2018 - Sep 2019
Associate Director, Head of Tmf Operations
Dia
Mar 2018 - Mar 2019
Clinical Quality Assurance Consultant
Dia
Jun 2017 - Oct 2018
Industry Engagement Lead
Bioverativ
Mar 2017 - Apr 2018
Clinical Quality Assurance Manager, Lead
University of South Florida
Mar 2016 - Mar 2017
Irb Research Compliance Officer
Stealth Investigations Llc
2011 - Mar 2016
Research Manager
Pfizer
2009 - 2011
Senior Clinical Trial Manager and Clinical Program Lead
Pfizer
Dec 2007 - Oct 2009
Lead Clinical Research Associate
Pfizer
Jul 2006 - Dec 2007
Clinical Trial Associate
Education:
Northeastern University 2017
Master of Science, Masters
University of Massachusetts Lowell
Bachelors, Bachelor of Arts
Suffolk University
University of Tampa
Skills:
Clinical Trials, Regulatory Affairs, Ich Gcp, Gcp, Sop, Cro, Pharmaceutical Industry, Fda, Regulatory Documentation, Quality Auditing, Ctms, Etmf, Document Management, Edc, Quality Control, Regulatory Guidelines, Regulations, Clinical Development, Regulatory Requirements, Biotechnology, Quality Inspection, Start Ups, Oncology, Clinical Research, Inspection Readiness, Regulatory Research, Regulatory Submissions, Cro Management, Institutional Review Board, Compliance
Certifications:
Human Subjects Research Certification
Tmf University Certification
Certified Gcp Auditor
Certified Veeva Vault Configuration Specialist
Certified Veeva Vault Business Administrator
Certified Veeva Vault System Administrator
Good Clinical Practice