Clinical Research Associate — Remote/Home-Office & Europe Travel

Rede Optimus; Antwerpen; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Rede Optimus is seeking a (Jr/Sr.) Clinical Research Associate located in Belgium to support clinical investigations across all phases of protocol execution. The role involves document development, regulatory submissions, site contracts, training, and monitoring activities.

The candidate should have completed studies in medicine, pharmacy, or a related natural science, be fluent in English and Dutch, and willing to travel regularly across Europe.

Qualifications

• Successfully completed studies in medicine, pharmacy, biochemistry or a comparable natural science discipline.
• Willing to learn the required medical topics and applicable regulatory guidelines.
• Fluent in English and Dutch; knowledge of French is a valuable asset.
• Mastered the common software packages (Word, Excel, PowerPoint, Adobe).
• An independent working environment and deadlines does not scare you.
• Willing to travel around Europe on a regular basis.
• Knowledge of GCP, completed Good Clinical Practice training is an advantage

Responsabilités

• Assist with development of specific study documents for clinical investigations during all phases of protocol execution (start-up, maintenance and study closure).
• Draft and submit study documents to Competent Authorities and Ethics committees.
• Assist Project Manager with development and negotiation of site contracts.
• Train site staff on procedures, source documentation, and CRF completion under PM supervision.
• Create site selection questionnaires.
• Support administrative tasks within clinical trials.
• Review study progress, data quality, patient compliance, and investigational product accountability; ensure GCP compliance.
• Conduct regular site visits, coordinate project meetings, and write visit-specific reports.
• Conduct remote monitoring activities and follow-up on safety events.
• Support Trial Master File and Site Master File preparation and maintenance

Connaissances

Fluent English

Fluent Dutch

Travel Europe

Independent worker

Deadline-oriented

Formation

Medicine

Pharmacy

Biochemistry

Natural sciences degree

Outils

Word

Excel

PowerPoint

Adobe

Description du poste

Rede Optimus is seeking a (Jr/Sr.) Clinical Research Associate located in Belgium to support clinical investigations across all phases of protocol execution. The role involves document development, regulatory submissions, site contracts, training, and monitoring activities.

The candidate should have completed studies in medicine, pharmacy, or a related natural science, be fluent in English and Dutch, and willing to travel regularly across Europe.