Aleksandra Wójcik
Senior Clinical Trial Assistant at Ryvu Therapeutics- Claim this Profile
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angielski Professional working proficiency
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włoski Elementary proficiency
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Credentials
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Data Validation & Effective Query Writing
ACDM: Association for Clinical Data ManagementOct, 2023- Sep, 2024 -
Data Integrity
ACDM: Association for Clinical Data ManagementSep, 2023- Sep, 2024 -
Management of non CRF data
ACDM: Association for Clinical Data ManagementSep, 2023- Sep, 2024 -
Building Data Management Success through Sponsor CRO Relationships
ACDM: Association for Clinical Data ManagementAug, 2023- Sep, 2024 -
Fundamentals of Clinical Data Management
ACDM: Association for Clinical Data ManagementAug, 2023- Sep, 2024 -
Data Management for Clinical Research
CourseraApr, 2023- Sep, 2024 -
Akademia Badań Klinicznych - szkolenie dla koordynatorów badań klinicznych w zakresie metodologii i prowadzenia badań klinicznych (moduł podstawowy oraz zaawansowany)
Agencja Badań MedycznychMay, 2022- Sep, 2024 -
Clinical Research Associate - VIARES Academy Program
VIARESNov, 2021- Sep, 2024 -
ICH Good Clinical Practice E6 (R2)
The Global Health NetworkAug, 2021- Sep, 2024 -
GCP - Dobra Praktyka Kliniczna
Soft CommunicationNov, 2018- Sep, 2024
Experience
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Ryvu Therapeutics
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Poland
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Biotechnology
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100 - 200 Employee
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Senior Clinical Trial Assistant
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Aug 2023 - Present
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Clinical Trial Assistant
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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
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Pratia
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Poland
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Research
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100 - 200 Employee
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Clinical Research Coordinator
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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
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GYNCENTRUM Sp. z o. o.
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Poland
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Hospitals and Health Care
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1 - 100 Employee
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Junior assistant for patient's service
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Sep 2020 - Jul 2021
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Uzdrowisko Kraków Swoszowice Sp. z o.o.
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Poland
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Hospitals and Health Care
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Physiotherapist
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May 2019 - Jul 2020
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BONA-MED
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Poland
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Hospitals and Health Care
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1 - 100 Employee
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Physiotherapist
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Mar 2018 - Jul 2019
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Education
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Uniwersytet Jagielloński w Krakowie
Studia podyplomowe, Badania kliniczne - metodologia, organizacja i zarządzanie -
Uniwersytet Jagielloński w Krakowie
Licencjat (Lic.), fizjoterapia