Karolina Żuk
Łódź,Poland
Summary
A 3-year experience as a Research Worker, 2-year experience as a Study Coordinator and almost 10-year experience as Clinical Research Associate within clinical trials. Currently also Central Monitoring Associate (dual role CRA/CMA). The broad scientific background and education gained with the Master's Degree in Biology and during studies in the area of Molecular Biology in combination of Bioorganic Chemistry. Gained knowledge and previous experience ensure highest quality of work in clinical research area. English skills and interpersonal abilities ensure very well communications within international project team environment.
Overview
16
16
years of professional experience
5
5
years of post-secondary education
Work history
Central Monitoring Associate (dual role with SCRA)
ICON plc
Warsaw, Poland
06.2023 - Current
- Supporting sites in daily work (first point of contact for protocol, procedures, manuals inquiries)
- Conducting Off-site Monitoring Visits
- Reviewing and to analyzing trial data remotely to draw conclusions on sites performance
- Preparing 'to do' list for sites on the basis of available data in study systems and trackers
- Ensuring all essential documents are up to date
- Supporting study team (Clinical Research Associates, Site Monitoring Associates and Clinical Trial Managers) in study conduct
Senior clinical research associate
ICON plc
Warsaw, Poland
04.2020 - Current
- Conducting all types of monitoring visit (depending on trial stage)
- Participating in audits and inspections
- Preparing monitoring visit reports
- Reviewing and following up on sites action items
- Building strong relationships with investigators, strengthening cooperation.
- Being visit leader for other CRAs
- Being mentor for new CRAs (training purposes)
Clinical Research Associate II
ICON plc (former PRA Health Sciences)
Warsaw, Poland
10.2017 - 03.2020
- Conducting all types of monitoring visit (depending on trial stage)
- Participating in audits and inspections
- Preparing monitoring visit reports
- Reviewing and following up on sites action items
- Building strong relationships with investigators, strengthening cooperation
Clinical Research Associate II (Sponsor dedicated)
KCR
Warsaw, Poland
04.2016 - 09.2017
- Conducting all types of monitoring visit (depending on trial stage) including remote visits
- Participating in audits and inspections
- Preparing monitoring visit reports
- Reviewing and following up on sites action items
- Participating in payment process for sites
- Building strong relationships with investigators, strengthening cooperation
Clinical Research Associate I (Sponsor dedicated)
KCR
Warsaw, Poland
12.2014 - 03.2016
- Conducting all types of monitoring visit (depending on trial stage) including remote visits
- Participating in audits and inspections
- Preparing monitoring visit reports
- Reviewing and following up on sites action items
- Participating in payment process for sites
Local Head of QC Compliance (dual role with SC)
CCBR Somed
Lodz, Poland
05.2013 - 11.2014
- Checking and maintaining the quality of performed clinical trials in accordance with ICH GCP principles and any relevant national and international law and
regulation for performing clinical trials - Checking and maintaining the quality of performed clinical trials in accordance with local work instructions and standard operating procedures and ensuring
that all relevant forms are filled and continuously updated
Study Coordinator
CCBR Somed
Lodz, Poland
10.2012 - 11.2014
- Obtaining thorough knowledge of the clinical trial protocols
- Obtaining thorough knowledge of the content of, and filing in, the Investigator File and the Patient File
- Ensuring, in co-operation with the PI, that the clinical trial protocol is followed
- Maintaining the Investigator File and filing the documents on a regular basis
- Ensuring, in cooperation with the PI, that the training of relevant staff and the completion of the delegations are completed and up to date
- Ensuring that the clinical trial staff are up to date on current clinical trial procedures/documents and other relevant information
- Resolving queries and other issues from Sponsor in co-operation with the PI
- Assisting the PI/Managing Director in logistical and administrative tasks/issues related to the clinical trial
- Preparing patient files, CRF's etc. for monitoring visits and assisting CRA during monitor visits
- Addressing monitoring issues in a timely manner in co-operation with the PI
- Participating in audits and inspections
Junior Member of Research Staff
Polish Academy of Sciences (CMMS)
Lodz, Poland
07.2012 - 10.2012
- Obtaining the throughout knowledge in the area of scientific research work
- Searching for new interesting areas to conduct scientific experiments
- Planning scientific experiments, analyze the results and draw conclusions from the obtained results
- Preparing and presenting materials/scientific work results on weekly scientific seminars with research staff
- Preparing and presenting materials/scientific work results on during national and international
conferences - Writing scientific articles in the co-operation with other members of research staff
- Participating in PhD studies
- Working on PhD thesis
- Conducting internships with students
Technical Research Worker – Biologist
Polish Academy of Sciences (CMMS)
Lodz, Poland
10.2009 - 06.2012
- Obtaining the throughout knowledge in the area of scientific research work
- Searching for new interesting areas to conduct scientific experiments
- Planning scientific experiments, analyze the results and draw conclusions from the obtained results
- Preparing and presenting materials/scientific work results on weekly scientific seminars with research staff
- Preparing and presenting materials/scientific work results on during national and international conferences
- Writing scientific articles in the co-operation with other members of research staff
- Participating in PhD studies
- Working on PhD thesis
Education
Master of Science - Biology (Genetics)
University of Lodz
Lodz 10.2004 - 06.2009
Skills
- Problem-solving
- Communication skills
- Public speaking
- Quality Assurance
- Strategic planning
Affiliations
- psychology
- interior design
- tennis
Timeline
Central Monitoring Associate (dual role with SCRA)
ICON plc
06.2023 - Current
Senior clinical research associate
ICON plc
04.2020 - Current
Clinical Research Associate II
ICON plc (former PRA Health Sciences)
10.2017 - 03.2020
Clinical Research Associate II (Sponsor dedicated)
KCR
04.2016 - 09.2017
Clinical Research Associate I (Sponsor dedicated)
KCR
12.2014 - 03.2016
Local Head of QC Compliance (dual role with SC)
CCBR Somed
05.2013 - 11.2014
Study Coordinator
CCBR Somed
10.2012 - 11.2014
Junior Member of Research Staff
Polish Academy of Sciences (CMMS)
07.2012 - 10.2012
Technical Research Worker – Biologist
Polish Academy of Sciences (CMMS)
10.2009 - 06.2012
Master of Science - Biology (Genetics)
University of Lodz
10.2004 - 06.2009
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