Justyna Leciejewska
Warsaw
Summary
Site Care Partner with over 7 years of experience in clinical trials industry within Clinical Research Organization and with 5 years of experience in independent monitoring. Well-organized, keen to learn and strongly motivated. Familiar with ICH-GCP and company SOP's.
Overview
8
8
years of professional experience
Work History
Site Care Partner
Parexel FSP
02.2024 - Current
- Collaborates with Site Monitor to ensure all activities post SIV are complete, ensuring the site and Site Monitor are prepared for FSFV (First Subject First Visit).
- Ensure the site has IP and sufficient supplies throughout the lifecycle of the study.
- Collaborates with the site, implementing recruitment strategies to meet enrollment goals.
- Responsible for the timely review and approval of Site Monitor's monitoring reports.
- Supports the revision and submission of Informed Consent Documents and amendments.
- Responsible for drug accountability and reconciliation as directed.
- Responsible for ensuring site preparedness for and executes the conduct of the Close Out Visit.
Senior Clinical Research Associate
Parexel
04.2022 - 01.2024
- Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).
- Build relationships with investigators and site staff.
- Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
- Address and resolve issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training.
- Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
- Review site recruitment plan in collaboration with the site staff on an ongoing basis.
- Perform and report on-site visits and remote contacts in accordance with the monitoring plan; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions, and concerns.
- Assess & manage test article/study supply including supply, accountability, and destruction/return status.
- Review & follow-up site payment status.
- Follow-up on CRF data entry, query status, and SAEs.
- Conduct on-site study-specific trainings.
- Perform site facilities assessments.
- Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training. Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.
- Uses site management experience and understanding of clinical trials methodology to demonstrate leadership and problem solving.
Clinical Research Associate II
Parexel
04.2021 - 04.2022
Clinical Research Associate I
Parexel
10.2019 - 03.2021
Clinical Research Associate I
IQVIA
04.2019 - 09.2019
Associate CRA
IQVIA
01.2019 - 03.2019
Clinical Trial Assistant
IQVIA
03.2017 - 12.2018
TMF Specialist
IQVIA
11.2016 - 03.2017
Education
Postgraduate Studies - Conducting And Monitoring of Clinical Trials
Kozminski University
Warsaw, Poland06.2016
Master's Degree - Public Health
Medical University of Warsaw
Warsaw, Poland06.2015
Skills
- Driving license cat B
- Languages: English (fluent), Polish (native)
Timeline
Site Care Partner
Parexel FSP
02.2024 - Current
Senior Clinical Research Associate
Parexel
04.2022 - 01.2024
Clinical Research Associate II
Parexel
04.2021 - 04.2022
Clinical Research Associate I
Parexel
10.2019 - 03.2021
Clinical Research Associate I
IQVIA
04.2019 - 09.2019
Associate CRA
IQVIA
01.2019 - 03.2019
Clinical Trial Assistant
IQVIA
03.2017 - 12.2018
TMF Specialist
IQVIA
11.2016 - 03.2017
Postgraduate Studies - Conducting And Monitoring of Clinical Trials
Kozminski University
Master's Degree - Public Health
Medical University of Warsaw
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