MedTech Clinical Research Associate | Travel‑Heavy

Pauwels Consulting; Machelen; Sur place; EUR 42 000 - 66 000; Plein temps

Résumé du poste

Pauwels Consulting seeks a Clinical Research Associate to oversee clinical activities across study sites for medical device projects. You will monitor sites, ensure data quality, and manage regulatory compliance with GCP and SOPs. Travel up to 80% to investigator sites is required.

Fluency in English and Dutch, a life sciences degree, and 2+ years in clinical research are expected; certification such as CCRA is a plus.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related field.
• 2+ years in clinical research, specifically medical device monitoring.
• Knowledge of international standards for medical devices and combination products.
• Proficiency in MS Office and clinical data systems.
• Strong organizational skills and ability to manage multiple sub-projects.

Responsabilités

• Manage clinical study site activities and oversee performance for assigned projects.
• Conduct site monitoring visits and verify safety and well-being of subjects.
• Ensure compliance with GCP, SOPs, and regulatory requirements.
• Support patient recruitment and retention and maintain Investigator Site Files.
• Interface with Investigators, IRBs/ECs, and vendors to meet milestones.

Connaissances

Site monitoring

Regulatory compliance

Data quality

Organization

Communication

Formation

Bachelor's degree in Life Sciences or related

Outils

MS Office

Clinical data systems

Description du poste

Pauwels Consulting seeks a Clinical Research Associate to oversee clinical activities across study sites for medical device projects. You will monitor sites, ensure data quality, and manage regulatory compliance with GCP and SOPs. Travel up to 80% to investigator sites is required.

Fluency in English and Dutch, a life sciences degree, and 2+ years in clinical research are expected; certification such as CCRA is a plus.