Aleksandra Wójcik

Senior Clinical Trial Assistant at Ryvu Therapeutics
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Contact Information
Location
Cracow, Małopolskie, Poland, PL
Languages
  • angielski Professional working proficiency
  • włoski Elementary proficiency

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Credentials

  • Data Validation & Effective Query Writing
    ACDM: Association for Clinical Data Management
    Oct, 2023
    - Sep, 2024
  • Data Integrity
    ACDM: Association for Clinical Data Management
    Sep, 2023
    - Sep, 2024
  • Management of non CRF data
    ACDM: Association for Clinical Data Management
    Sep, 2023
    - Sep, 2024
  • Building Data Management Success through Sponsor CRO Relationships
    ACDM: Association for Clinical Data Management
    Aug, 2023
    - Sep, 2024
  • Fundamentals of Clinical Data Management
    ACDM: Association for Clinical Data Management
    Aug, 2023
    - Sep, 2024
  • Data Management for Clinical Research
    Coursera
    Apr, 2023
    - Sep, 2024
  • Akademia Badań Klinicznych - szkolenie dla koordynatorów badań klinicznych w zakresie metodologii i prowadzenia badań klinicznych (moduł podstawowy oraz zaawansowany)
    Agencja Badań Medycznych
    May, 2022
    - Sep, 2024
  • Clinical Research Associate - VIARES Academy Program
    VIARES
    Nov, 2021
    - Sep, 2024
  • ICH Good Clinical Practice E6 (R2)
    The Global Health Network
    Aug, 2021
    - Sep, 2024
  • GCP - Dobra Praktyka Kliniczna
    Soft Communication
    Nov, 2018
    - Sep, 2024

Experience

    • Poland
    • Biotechnology
    • 100 - 200 Employee
    • Senior Clinical Trial Assistant
      • Aug 2023 - Present

    • Clinical Trial Assistant
      • Jun 2022 - Aug 2023

      • Working closely with Clinical Operations team members to ensure successful clinical trial planning, execution and delivery • Assisting in study team meetings preparation• Performing study related administrative tasks to support the Clinical Operations team as needed • Tracking and reconciliation of study related materials e.g., study samples and investigational medicinal product • Assisting in maintenance of study related tracking tools • Assisting in preparation of study specific documents, including finalization, distribution, document revision, management and archiving. • Assisting with review of Trial Master File (eTMF) for completeness and timely provision of TMF content • Assisting with quality control checks for key study related materials e.g. protocols, study reports • Contributing in the development of clinical trial management best practice processes and procedures • Contributing to department initiatives to improve the efficiency and effectiveness of the Clinical Operations team • Support identification of vendors and collaborators • Supporting Study Manager, Lead-CRA and/or CRA to ensure successful clinical trial planning, execution and delivery• Providing Study Manager, Lead-CRA and/or CRA with reports, trackers, summaries as required in the study Show less

    • Poland
    • Research
    • 100 - 200 Employee
    • Clinical Research Coordinator
      • Jul 2021 - Jun 2022

      Coordinating hematooncology trials: ○Supervision of patient's documentation ○Creating study specific data collection forms ○Scheduling participant's study visits ○Monitoring of laboratory results and radiologic assesments ○Data entry into the eCRF ○Query resolution ○Maintaining essential documents in the ISF's ○Cooperation with the Study Team, CRA's, CTA's, Vendor's ○Documenting study staff's training activities ○Ensuring compliance with the trial approved protocol Coordinating hematooncology trials: ○Supervision of patient's documentation ○Creating study specific data collection forms ○Scheduling participant's study visits ○Monitoring of laboratory results and radiologic assesments ○Data entry into the eCRF ○Query resolution ○Maintaining essential documents in the ISF's ○Cooperation with the Study Team, CRA's, CTA's, Vendor's ○Documenting study staff's training activities ○Ensuring compliance with the trial approved protocol

    • Poland
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Junior assistant for patient's service
      • Sep 2020 - Jul 2021
    • Poland
    • Hospitals and Health Care
    • Physiotherapist
      • May 2019 - Jul 2020
    • Poland
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Physiotherapist
      • Mar 2018 - Jul 2019

Education

  • Uniwersytet Jagielloński w Krakowie
    Studia podyplomowe, Badania kliniczne - metodologia, organizacja i zarządzanie
    2019 - 2020
  • Uniwersytet Jagielloński w Krakowie
    Licencjat (Lic.), fizjoterapia
    2014 - 2017

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