Omschrijving

I am a Clinical Research professional with hands-on experience supporting and monitoring clinical trials in compliance with ICH-GCP and EU regulations.

I have worked as a Clinical Trial Assistant and CRA, supporting study start-up, site management, essential documents, TMF/ISF review, monitoring activities, and site communication.

I am detail-oriented, well-organized, and experienced in working with sponsors, CROs, and investigational sites across different therapeutic areas. I support clinical teams with accuracy, regulatory compliance, and clear communication to ensure smooth trial execution.

Available for remote or hybrid assignments including CTA support, CRA support, TMF review, site start-up, and clinical documentation.

Branche-expertise

Talen

Engels
Tweetalig / moedertaal

Voorkeuren voor werkplek

Uitsluitend remote

Werkt voornamelijk remote

Icon clinical research
Clinical Research Associate
GEZONDHEID & WELLNESS
augustus 2025 - Vandaag (10 maanden)
Mechelen, België
Responsible for site monitoring activities, site start-up support, and review of essential documents in compliance with ICH-GCP. Ensure data quality, accurate documentation, and effective collaboration with investigator sites and internal teams.
Sillar Clinical
Clinical Trial Administrator
GEZONDHEID & WELLNESS
december 2023 - april 2025 (1 jaar en 4 maanden)
Ghent, België
Detail-oriented Clinical Trial Assistant with experience supporting EU and global clinical studies in compliance with ICH-GCP, EU CTR, and ALCOA+. I provide reliable operational support to CRAs and study teams, including TMF/ISF maintenance, study start-up support, essential documents tracking, site coordination, and monitoring visit preparation/follow-up. Highly organized, proactive, and comfortable working independently or within CRO/sponsor teams.
Communication Organisation Time management Documentation management