Joseph Kim

Experience

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  Sogang University

  May 2012 - Aug 2012

  Laboratory Assistant

  Department of Molecular and Cellular BiologyPrincipal Investigator: Jungho Kim• Proactively studied basic molecular cloning and related protocols• Performed standard laboratory procedures including preparation of protocol reagents, cellculture maintenance, and stocking materials• Assisted graduate students with study procedures and bioassays

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  University Health Network

  Jan 2015 - Oct 2015

  Clinical Research Assistant

  Toronto Western Hospital rTMS ClinicPrincipal Investigator: Dr. Jonathan Downar• Completed and checked case report forms for accuracy• Organized current patient files and archived completed patient files• Input and checked patient information and depressive symptom assessments into studydatabase• Created database containing all patients treated in the rTMS clinic for MDD, OCD, ED,and PTSD, used for all volunteer research projects• Conducted research project involving FSL VBM analysis of OCD and EDpatient populations to determine biomarkers for responsiveness to TMS treatment Show less

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  CVS Pharmacy

  Dec 2015 - Feb 2016

  Pharmacy Technician

  • Processed and filled prescriptions• Performed prescription pick-up procedures• Provided customer service

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  Parexel

  Feb 2016 - Mar 2019

  • Main point of contact for clinical sites, accountable for quality and delivery of sites from Initiation to Termination of trial• Ensure quality and integrity of study data, and ensure that sites are in compliance with protocol, study requirements, GCP, and applicable regulatory requirements• Conduct Qualification, Initiation, Interim Monitoring, and Termination visits, and generate contact and site visit reports• Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents• Assess and manage test article and study supply inventory, accountability, and destruction/return status• Review site recruitment plans and take action to drive recruitment in collaboration with site staff• Review and facilitate site payments• Prepare training slides and lead CSM forums to train CSMs on topics of interest Show less • Serve as the primary point of contact for research sites, conduct general site contacts, and generate contact reports• Identify and ensure timely closure of site issues and EDC queries per ICH GCP guidelines• Collect, maintain, and submit documents to the project’s TMF• Ensure accuracy project tracking in CTMS and site staff have all required access to relevant study systems• Regularly monitor site level data in EDC to ensure data integrity and timeliness of entry• Lead initiative to train designated CMAs to identify missing items in TMF prior to QC findings Show less

  • Clinical Site Manager

    Jan 2018 - Mar 2019

  • Clinical Research Associate

    Oct 2017 - Dec 2017

  • Clinical Monitoring Associate

    Feb 2016 - Oct 2017
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  Blueprint Medicines

  Mar 2019 - Aug 2020

  Clinical Study Associate

  • Participates in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs• Supports complex clinical trial activities in support of the Clinical Study Manager and other team members• Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)• Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management• Ensures tracking of patient status throughout the study at investigative sites• Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule• Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting• Review monitoring trip reports, track data query reports, site visit metrics, and overall site performance• Attends site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with CRO• Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues• Assists in the preparation of, and may present at investigator vendor meetings and workshops• Actively involved in the performance of study feasibility assessments• Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation Show less

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  Alimentiv

  Aug 2020 - Mar 2022

  • Senior Clinical Research Associate

    Sept 2021 - Mar 2022

  • Clinical Research Associate II

    Aug 2020 - Sept 2021
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  Kowa Research Institute, Inc.

  Mar 2022 - now

  Associate Project Manager