Experience

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  Quintiles transnational, inc.

  Jan 1997 - Jan 2006

  Sr. monitor early development, lead dm, phase i project manager, and cru charge rn
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  Janssen pharmaceutical, company of johnson & johnson,

  Jan 2006 - Jan 2013

  Clinical research specialist
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  The janssen pharmaceutical companies of johnson & johnson

  Jan 2006 - Feb 2022

  Sr. site manager
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  Two bar enterprise. inc

  Jan 2013 - May 2015

  Contract clinical research specialist

  Clinical site monitoring, quality control, and data audits through contractual clinical monitoring services. Providing protocol management and execution of phase 1-3 trials with extensive Phase 1/early development experience. Expertise in site assessments, subject recruitment with retention planning, site initiation, interim monitoring, analytical monitoring and site closure to ensure trial related activities in compliance with standard procedures, federal and local regulations. Collaborate with Clinical Project Lead, Trial Managers, Data Management and Sponsor to ensure trial conduct is completed within budget and timelines, serving as the primary liaison between investigational site staff and central team ensuring data integrity and timely completion of trial conduct. Work performed through contracts with Cardinal Health, Beckloff & Associates, TRIO, SGS and PRA.Conduct analytical services and quality control audits of global phase 3 regulatory documents including protocols, Investigator Brochures, Site Records, regulatory submissions, regulatory applications, and Trial Master File. Work performed through contact with Cardinal Health, Beckloff & Associates. Show less

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  Pra hs - strategic solutions

  May 2015 - May 2016

  Cra iii performing duties of a sr site manager for janssen edcp

  Monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

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  Janssen inc.

  Sept 2017 - May 2022

  Retired from Janssen Pharmaceuticals May2022 Responsible for the local management of a trial in one or more countries acting as the primary point of contact at a country level for assigned studies, performing the Local Trial Manager (LTM) tasks, Global Trial Manager (GTM) tasks for ED&CP studies to which no GTM has been assigned, and may perform the Site Manager (SM) tasks, while contributing to process improvement initiatives, as well as the training and mentoring of Site Managers and Clinical Trial Assistants.

  • Sr. Independent Drug Monitor Manager/Trial Manager

    Sept 2021 - May 2022

  • Senior Clinical Trial Manager

    Sept 2006 - May 2022

  • Trial Manager, US Early Development & Clinical Pharmacology with Janssen Pharmaceuticals

    Sept 2017 - Feb 2022
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  The janssen pharmaceutical companies of johnson & johnson

  Jun 2022 - Jan 2023

  Retired