Oncology Clinical Trials Specialist I

CellCarta; Antwerpen; Sur place; EUR 42 000 - 65 000; Plein temps

Résumé du poste

CellCarta is seeking a Clinical Study Specialist I to ensure site-level regulatory documentation, monitoring visits, and close-out activities are executed with precision. You will liaise with Project Management, Regulatory Affairs, and QA to maintain audit readiness across oncology trials.

The role requires 2+ years in clinical research, GCLP/GDP knowledge, and English fluency. It is a full-time, 100% onsite position within the Clinical Operations team.

Qualifications

• 2+ years hands-on experience in clinical research (CRO or pharma).
• Understanding of GCLP and GDP is required.
• Professional fluency in English is mandatory.
• Familiarity with oncology protocols and high-volume documentation.

Responsabilités

• Monitor oversight and manage action items to resolution with monitors and site staff.
• Collect, QC, and file site-level essential documents for SIVs and activation.
• Oversee close-out logistics and ensure all documents are reconciled before site closure.
• Prepare document packages for Regulatory Affairs and track amendments; maintain audit readiness.
• Manage access to trial systems (EDC, IRT, eTMF) and support investigator meetings.
• Maintain central monitoring dashboards for real-time visibility into open action items and compliance metrics.

Connaissances

Clinical research experience

GCP/GDP knowledge

English fluency

Organizational skills

Formation

Bachelor’s or Master’s in Life Sciences/Pharmacy

Outils

eTMF (Veeva Vault)

CTMS platforms

Description du poste

CellCarta is seeking a Clinical Study Specialist I to ensure site-level regulatory documentation, monitoring visits, and close-out activities are executed with precision. You will liaise with Project Management, Regulatory Affairs, and QA to maintain audit readiness across oncology trials.

The role requires 2+ years in clinical research, GCLP/GDP knowledge, and English fluency. It is a full-time, 100% onsite position within the Clinical Operations team.