Kerensa O'Loughlin
Associate Director, Global Study Start Up at Advanced Clinical- Claim this Profile
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Bio
Experience
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Advanced Clinical
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United States
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Biotechnology Research
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700 & Above Employee
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Associate Director, Global Study Start Up
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Apr 2022 - Present
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Regulatory Start Up Manager
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Oct 2018 - Present
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Regional Manager, GSSU, North America
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Aug 2019 - Apr 2022
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Syneos Health
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United States
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Biotechnology Research
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700 & Above Employee
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Study Start Up Project Lead
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Oct 2015 - Oct 2018
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inVentiv Health Clinical
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United States
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Pharmaceutical Manufacturing
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500 - 600 Employee
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GSSU Specialist II
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Jul 2013 - Oct 2015
Cary, North Carolina
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Nor Consult, LLC
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United States
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Research Services
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1 - 100 Employee
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Regulatory Specialist
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Oct 2009 - Mar 2013
Greater Seattle Area • Reviewed and negotiated confidentiality agreements and clinical trial agreements, obtaining input from Sponsor and/or Legal Council as appropriate • Managed all IRB/EC related activities including initial submissions, modifications, continuing reviews and study closures • Developed informed consent templates for all new studies based on Investigative Protocol • Reviewed and approved all site’s modifications to informed consents • Created various documents for new studies including… Show more • Reviewed and negotiated confidentiality agreements and clinical trial agreements, obtaining input from Sponsor and/or Legal Council as appropriate • Managed all IRB/EC related activities including initial submissions, modifications, continuing reviews and study closures • Developed informed consent templates for all new studies based on Investigative Protocol • Reviewed and approved all site’s modifications to informed consents • Created various documents for new studies including but not limited to operations manuals and patient brochures • Ensured all required documents were disseminated and received for study start-up • Collaborated in the creation and development of investigative protocols, investigator brochures, and initiation materials Show less
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Metabasis Therapeutics
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Assistant
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Feb 2005 - Nov 2008
La Jolla, CA
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Administrative Assistant, Regulatory Strategy
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Nov 2003 - Oct 2004
La Jolla, CA
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Project Assistant/Regional Support Team
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Nov 2001 - Nov 2003
La Jolla, CA
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Institution Review Board Assistant
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Jun 1999 - Oct 2001
La Jolla, CA
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Education
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University of Phoenix
BSBM, Business Administration and Management, General
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