Summary
Overview
Work History
Education
Skills
Awards
Timeline
Generic

Maria Johnson

Oakland

Summary

Dynamic Clinical Research Associate with iQVIA, skilled in project management and site monitoring. Proven ability to enhance site compliance and performance through effective collaboration and communication. Experienced in utilizing CTMS and EDC systems, ensuring high-quality study execution while fostering strong relationships with clinical teams. Passionate about driving successful clinical outcomes.

Overview

11
11
years of professional experience

Work History

Clinical Research Associate

IQVIA
06.2016 - Current
  • Perform monitoring and site management work for 3-4 protocols at a time.
  • Work with partner sites to adapt, drive, and track project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites, and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol, and adherence to applicable regulations.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
    Ensure copies or originals of site documents are available for filing in the Trial Master File (TMF), and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP, ICH, and local regulatory requirements.
    Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
    • Act as a mentor for new CRAs, including conducting co-monitoring and training. Collaborate and liaise with study team members for project execution support, as appropriate.

Clinical Trials Assistant

IQVIA
05.2015 - 05.2016
  • Assist the Study Lead with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports, according to the scope of work and standard operating procedures.
  • Assist with the periodic review of study files for accuracy and completeness.
  • Assist CTLs with the preparation, handling, and distribution of Clinical Trial Supplies, and the maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
  • Perform assigned administrative tasks to support team members with clinical trial execution.

Bioprocess Technician

Bayside Solutions/ Genentech Inc.
06.2014 - 05.2015
  • Complete and review production tickets and documents, adhering to Good Documentation Practices.
  • Execute multiple standard operating procedures for several commercial production campaigns.
  • Responsible for managing large-scale fermentation equipment, and adhering to regulatory agency guidelines.
  • Maintain documentation files daily, and review documentation accuracy.
  • Perform common laboratory practices and utilize aseptic techniques while preparing chemical solutions.
  • Attend daily shift change meetings, communicate task timeline execution to the shift lead, and provide end-of-shift status to the incoming team.
  • Conduct internal weekly facility audits, adhering to 5S business organizational standards.
  • Develop efficiency in utilizing the company’s proprietary tracking software programs.

Education

B.S. - Biological Sciences

University of California
Merced, USA
01.2014

Skills

  • Project management, site monitoring
  • Team collaboration with clinical site staff and sponsor operations teams
  • Experience working with clinical operations systems: CTMS, Veeva Vault, EDC, IxRS
  • Therapeutic area experience in oncology and CNS

Awards

  • IQVIA Impact Reward - SME Mentor, 12/2022
  • FSP Above and Beyond Award - Delivering with Agility, 12/2022
  • IQVIA Impact Reward - Managing High Workload, 12/2021

Timeline

Clinical Research Associate

IQVIA
06.2016 - Current

Clinical Trials Assistant

IQVIA
05.2015 - 05.2016

Bioprocess Technician

Bayside Solutions/ Genentech Inc.
06.2014 - 05.2015

B.S. - Biological Sciences

University of California

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Maria Johnson