Myra Miller

Experience

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  Arkios

  Sept 2002 - Jun 2003

  Midwest Regional Clinical Research Associate

   Primary responsibilities included qualifying, initiating, monitoring and closing clinical trial sites in accordance to applicable SOPs and regulatory guidelines Additional responsibilities included verifying test article accountability, reviewing regulatory document files, conducting potential investigator interviews and adequately documenting these activities.

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  DermTech International

  Jun 2003 - Jun 2004

  Clinical Research Associate

   Primary responsibilities included qualifying, initiating, monitoring and closing clinical trial sites in accordance to applicable SOPs and regulatory guidelines Additional responsibilities included verifying test article accountability, reviewing regulatory document files, conducting potential investigator interviews and adequately documenting these activities.

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  PRACS Institute, Ltd.

  Jun 2004 - Jul 2006

  Clinical Research Associate

   Primary responsibilities included qualifying, initiating, monitoring and closing clinical trial sites in accordance to applicable SOPs and regulatory guidelines Additional responsibilities included verifying test article accountability, reviewing regulatory document files, conducting potential investigator interviews and adequately documenting these activities.  Lead CRA duties included assisting Project Management staff with vendor and sponsor requests, case report form (CRF) creation, site source documentation tools creation, and creation of standardized logs and forms for study-specific requirements. Show less

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  INC Research

  Jul 2006 - Sept 2013

   Primarily responsible for management and coordination of Clinical Research Associates (CRAs) on clinical research projects while serving in the Lead CRA role Responsible for monitoring all phases of clinical trials; ensures adherence to Good Clinical Practice, Investigator integrity and compliance with all study procedures. Participates in business Development client presentation and bid defenses as requested. Attends all study specific team meetings to include: Business Development hand-off, kick-off meetings, study start-up, and investigator meetings. Develops and presents clinical materials at study meetings. Provides training to CRAs on protocol, CRF completion, study specific systems, sponsor SOPs, and clinical plans and guidelines for the study. Communicates with the monitoring team to ensure understanding of the study timelines and compliance with clinical deliverables. Develops clinical plans and guidelines, including clinical monitoring plans. Ensures compliance with monitoring intervals according to the project requirements. Resolves protocol questions with the PM and patient related issues with the medical monitor. Responsible for the supervision of up to seven direct reports. Develops training plan and ensures orientation and training are scheduled for direct reports. Mentors and coaches CRAs in cases where training and performance needs are identified. Ensures target CRA utilization is met. Assists management in the quarterly evaluation of and feedback on team members’ individual job performance. Completes on-site CRA assessments (observations and sign-off evaluations) of entry-level CRAs, identifying performance needs and accomplishments. Handled all aspects of site selection, site initiation, site monitoring, and close out visit. Proactively managed patient enrollment activities, site relationships, and data retrieval. Show less

  • Clinical Team Leader

    May 2008 - Sept 2013

  • Senior Clinical Research Associate

    Mar 2007 - May 2008

  • Clinical Research Associate II

    Jul 2006 - Mar 2007
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  PRA Health Sciences

  Sept 2013 - Jul 2021

  • Senior Project Manager

    Apr 2021 - Jul 2021

  • Project Manager

    Feb 2020 - Apr 2021

  • Clinical Team Manager III

    May 2016 - Feb 2020

  • Clinical Team Manager II

    Sept 2013 - Apr 2016
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  ICON plc

  Jul 2021 - Nov 2021

  Senior Project Manager
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  Syneos Health

  Nov 2021 - now

  • Project Director, Global Vaccines Center of Excellence

    May 2023 - now

  • Associate Director Project Management

    Nov 2021 - May 2023