Clinical Research Associate (CRA)

Archer Research is a young, dynamic, and fast-growing Contract Research Organization (CRO) located in Bioville, Diepenbeek — a vibrant hub for health innovation. We support clinical studies with medical devices across Europe and are looking for a Clinical Research Associate (CRA) to strengthen our team.

Your Role

As a CRA you are responsible for setting up, managing, and monitoring clinical studies in line with all regulatory requirements and Good Clinical Practice (GCP). You are the primary contact for the study teams and safeguard the quality and integrity of the data.

Your responsibilities include:

• Preparing and following up on submissions to ethics committees and/or national authorities in European member states.
• Selecting potential investigators and sites, including assessment of facilities, equipment, and staff.
• Conducting international pre-study visits, site initiations, and close-out visits.
• Monitoring clinical studies (remote and on-site) to ensure compliance with protocol, GCP, ICH-GCP, and MDR regulations.
• Supporting and advising investigators and site staff.
• Providing training to site teams and sponsors.
• Coordinating investigator meetings.
• Following up on patient recruitment and retention.
• Ensuring timely and accurate reporting of Adverse Events (AE) and Serious Adverse Events (SAE).
• Managing Trial Master File (TMF) and Investigator Site Files (ISF).
• Developing and managing study-specific documentation, tools, and templates.
• Monitoring study budgets.
• Working according to SOPs and contributing to continuous improvement.

Who Are We Looking For?

• First experience as a CRA is a must-have, including monitoring within clinical studies.
• Knowledge of MDR is a must and a strong plus for your profile.
• Master’s or PhD degree in Life Sciences.
• Familiarity with GCP and ISO standards (ISO14155, ISO9001).
• Excellent communication skills in English; knowledge of Dutch, German and/or French is a plus.
• Willingness to travel regularly within Europe (international site visits are an essential part of this role).
• Proactive, flexible, and result-driven, with strong attention to detail and accuracy.
• Strong organizational and time management skills, able to handle multiple priorities across different studies.
• Good computer skills (MS Office, EDC systems).

What We Offer

• A competitive salary package with benefits: company car, eco vouchers, mobile phone with subscription, comprehensive insurance package (hospitalization, income protection, pension plan), and a flat-rate expense allowance.
• A close-knit team of professionals with short lines to management.
• Opportunities to work on cutting-edge clinical research projects that directly contribute to safer healthcare and patient well-being.
• Internal coaching and external training for continuous development.
• A supportive environment that values autonomy and well-being.

Ready to further build your career as a CRA in an international context?

Apply today and come say 'hi' to our lovely team!