Joanna Sybicka
Warsaw
Profil zawodowy
Clinical research professional with solid experience in study start-up, regulatory submissions, site management, TMF/ISF documentation and clinical trial coordination across international clinical trials. Experienced in supporting country and site start-up activities, maintaining accurate trial documentation and tracking study progress in collaboration with local and global project teams, investigators and vendors.
Strong knowledge of ICH/GCP requirements, clinical trial documentation and regulatory processes, including submissions to Regulatory Authorities and Ethics Committees under EU CTR. Proven ability to coordinate multiple activities, maintain high-quality documentation and communicate effectively with cross-functional stakeholders.
Podsumowanie
2
2
Languages
2
2
years of post-secondary education
8
8
years of professional experience
Doświadczenie
Senior In-house CRA
Fortrea
Warsaw
2025.06 - 2026.01
- Supported day-to-day study start-up and site management activities, maintaining regular communication with clinical sites to ensure timely completion of required activities.
- Supported local and global project teams throughout study set-up and ongoing study activities.
- Supported the adaptation of site-specific Informed Consent Forms and distribution of key study documents, including Protocols, ICFs, Investigator Brochures and Agreements.
- Prepared and maintained Investigator Site Files (ISF).
- Provided oversight of country- and site-level eTMF documentation, ensuring completeness, accuracy and quality.
- Coordinated monitoring activities at clinical trial sites, supporting adherence to study protocols and timely resolution of site-related issues.
- Assisted with the preparation and review of regulatory documentation, ensuring compliance with GCP and applicable regulations.
Start-up Specialist
Fortrea formerly Covance assigned to MSD
Warsaw
2023.04 - 2025.06
- Planned, prepared and submitted regulatory documents to Health Authorities and IRB/EC under the EU Clinical Trials Regulation (EU CTR) at country level.
- Reviewed and locally adapted Informed Consent Forms, recruitment materials and other patient-facing study documents.
- Coordinated and reviewed translations of relevant study documentation.
- Tracked project status and provided oversight of regulatory activities to support study milestones and deliverables.
- Performed quality reviews of study documents to ensure completeness and compliance with applicable requirements.
In-house CRA 2
Covance assigned to MSD
Warsaw
2019.08 - 2023.03
- Supported feasibility and site identification activities, including collection of Confidential Disclosure Agreements and Site Feasibility Questionnaires.
- Supported and tracked clinical trial submissions to Regulatory Authorities and Ethics Committees.
- Supported the adaptation of country- and site-specific Informed Consent Forms.
- Maintained regular communication with clinical sites to ensure timely completion of study start-up and maintenance activities.
- Collected and reviewed Green Light Package documentation required for Investigational Product release to sites.
- Prepared and maintained Investigator Site Files (ISF), in both paper and electronic formats.
- Provided oversight of country- and site-level eTMF documentation, ensuring completeness and appropriate quality.
- Prepared, filed and archived project documentation and study reports, including line listings and annual study reports.
- Supported clinical trial supplies management.
- Mentored less experienced team members.
Financial Clinical Coordinator
Covance assigned to MSD
Warsaw
2019.02 - 2019.08
- Managed country-level Investigator payments for assigned clinical studies from end to end.
- Collected and consolidated information from multiple teams, systems and tools in a timely and proactive manner.
- Acted as a point of contact for Investigator-related queries across assigned studies.
Administrative Associate
ICON formerly PRA Health Sciences
Warsaw
2018.02 - 2019.01
- Supported financial processes, expense reporting and freelancer agreements.
- Cooperated with internal and external vendors.
Wykształcenie
MA - Master of Management and Marketing
Warsaw University of Life Science
Warsaw 2005.10 - 2007.06
Umiejętności
- Clinical Trial Study Start-Up
- Site Identification & Feasibility
- Regulatory & Ethics Committee Submissions
- EU Clinical Trials Regulation (EU CTR)
- Site & Country Start-Up Activities
- Investigator Site File (ISF)
- eTMF Oversight & Document Quality
- Trial Documentation & Tracking
- Informed Consent Forms & Patient Materials
- Site Communication & Coordination
- Investigator & Site Support
- Clinical Trial Supplies Management
- Monitoring Activity Coordination
- ICH/GCP & Documentation Practices
- Cross-functional & Vendor Collaboration
- MS Office & Clinical IT Applications
- Strong Organization & Prioritization
- Communication & Problem-Solving
Languages
English
Advanced
C1
French
Elementary
A2
Oś czasu
Senior In-house CRA
Fortrea
2025.06 - 2026.01
Start-up Specialist
Fortrea formerly Covance assigned to MSD
2023.04 - 2025.06
In-house CRA 2
Covance assigned to MSD
2019.08 - 2023.03
Financial Clinical Coordinator
Covance assigned to MSD
2019.02 - 2019.08
Administrative Associate
ICON formerly PRA Health Sciences
2018.02 - 2019.01
MA - Master of Management and Marketing
Warsaw University of Life Science
2005.10 - 2007.06