Associate Director, Global Study Start Up Lead at AbbVie @ (October 2021 - February 2022)
Study Start Up Project Manager (Sr Mgr), FSP* @ (October 2020 - October 2021)
Study Start Up Critical Path Manager @ (January 2020 - October 2020)
Senior Site Intelligence and Activation (SIA) Team Manager, Global @ (April 2017 - September 2019)
Site Intelligence and Activation (SIA) Team Manager, Global @ (July 2014 - March 2017)
Senior Country Approval Specialist (formerly Principal Clinical Submission Specialist) @ (January 2012 - July 2014)
Senior Regional Clinical Research Associate @ (May 2010 - January 2012)
Clinical Trial Manager @ AVI Biopharma Inc (October 2009 - March 2010)
Clinical Research Associate II @ Quintiles (November 2008 - September 2009)
Clinical Research Associate I @ (June 2008 - November 2008)
Clinical Research Site Director @ Radiant Research (December 2007 - April 2008)
Contract Clinical Manager @ (October 2007 - December 2007)
Clinical Research Associate and Clinical Operations Manager and Team Lead @ GenVec (April 2007 - September 2007)
Clinical Research Operations Manager @ (June 2005 - March 2007)
Regulatory Affairs Specialist @ (September 2004 - June 2005)
Contract Protocol Monitor and Data Manager @ (June 2004 - September 2004)
Contract Consultant, Clinical Research Coordinator @ Oregon Center for Clinical Investigations, Inc. (November 2003 - April 2004)
Clinical Study Coordinator (Bone and Mineral Unit) @ (February 2002 - March 2003)
Clinical Study Coordinator (Blood Brain Barrier and Neuro-Oncology Program) @ (July 2001 - February 2002)
Research Assistant 1 and Assistant Study Coordinator and Counselor (Smoking Cessation Center) @ (September 2000 - July 2001)
Research Assistant 4 - Project Alliance @ Child and Family Center, University of Oregon (January 1999 - September 2001)
Research Assistant 2 - Project Alliance @ Child and Family Center, University of Oregon (August 1997 - December 1998)
Research Assistant - Project SUCCEED @ Regional Research Institute, Portland State University (October 2000 - May 2001)
Amy Conrad-Smith Education
University of Portland
Bachelor's degree (Psychology and German)
1996-1998
School of Medicine and Health Sciences, The George Washington University
IN PROGRESS = MSHS (Clinical Research Administration)
2006
Amy Conrad-Smith Skills
Informed Consent
Good Clinical Practice (GCP)
Institutional Review Board (IRB)
U.S. Food and Drug Administration (FDA)
Electronic Data Capture (EDC)
Clinical Research
Clinical Development
Clinical Trials
Project Management
Project Planning
Project Coordination
Project Delivery
Project Finance
Project Implementation
ICH GCP
Regulatory Affairs
Regulatory Submissions
U.S. Title 21 CFR Part 11 Regulation
Regulatory Requirements
Standard Operating Procedure (SOP)
Quality Assurance
Quality Improvement
Process Optimization
Budget Management
Risk Management
Clinical Trial Management System (CTMS)
Management
Team Leadership
Cross-functional Team Leadership
Team Motivation
Team Management
Client Relations
Mentoring
CRFs
Drug Accountability
Patient Recruitment
Oncology Clinical Research
Clinical Research Associates
General Data Protection Regulation (GDPR)
Regulatory Documentation
Global Regulatory Compliance
Team Coordination
Team Mentoring
Project Team Management
Multi-Cultural Team Leadership
SOP Development
Issue Identification
Trial Master File (TMF)
Timeline Development
Strategic Planning
Contract Research Organization (CRO)
Amy Conrad-Smith Summary
Amy Conrad-Smith, based in Tacoma, WA, US, is currently a Senior Project Manager at KCR. Amy Conrad-Smith brings experience from previous roles at Novotech, Joulé and Parexel. Amy Conrad-Smith holds a 1996 - 1998 Bachelor's degree in Psychology and German @ University of Portland. With a robust skill set that includes Informed Consent, Good Clinical Practice (GCP), Institutional Review Board (IRB), U.S. Food and Drug Administration (FDA), Electronic Data Capture (EDC) and more. Amy Conrad-Smith has 3 emails and 1 mobile phone numbers on RocketReach.
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