Clinical Research Associate

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

Our client, a leading MedTech organization, is seeking a Clinical Research Associate to manage clinical activities across various study sites. The role focuses on overseeing site performance, conducting monitoring visits, and ensuring the delivery of high-quality data for clinical projects.

• Manage clinical study site activities and oversee performance for assigned medical device projects.
• Conduct site monitoring visits and verify the safety and well-being of study subjects.
• Execute clinical trial activities in compliance with GCP, SOPs, and applicable regulatory requirements.
• Support patient recruitment and retention activities while maintaining Investigator Site Files.
• Address and resolve site-level issues by implementing corrective and preventive actions when required.
• Interface with Investigators, IRBs/ECs, and vendors to ensure project milestones are met.

• Bachelor's degree in Life Sciences, Nursing, or a related scientific field.
• You have 2+ years of experience in clinical research, specifically involving medical device monitoring.
• You bring knowledge of international standards and regulations applied to medical devices and combination products.
• You possess proficiency in Microsoft Office and experience with clinical data systems.
• You have strong organizational skills and the ability to manage multiple sub-projects simultaneously.
• You're flexible and willing to travel up to 80% of the time to various investigator sites.
• You are fluent in English and Dutch with the ability to read medical notes and converse confidently.

Nice to Haves

• Professional certifications such as CCRA, RAC, or CDE.
• Clinical experience within the field of electro cardiophysiology.
• Active knowledge of French.