Senior Clinical Research Associate

Arcadis; Machelen; Sur place; EUR 65 000 - 100 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Global project teams

Professional development

Flexible environment

Résumé du poste

Arcadis is seeking an experienced Senior Clinical Research Associate to support and monitor clinical studies within a MedTech environment. You will manage multiple study sites, ensure protocol and GCP compliance, and drive data quality and study performance.

Applicants should have 4+ years of site monitoring experience, strong communication skills, and willingness to travel up to 80% of the time. English fluency is required, with a scientific background preferred.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biological Sciences, Nursing, Pharmacy, Biomedical Sciences, or related field.
• Minimum of 4 years of recent site monitoring experience as a Clinical Research Associate.
• Experience in clinical research is required.
• GCP knowledge and regulatory understanding are essential.

Responsabilités

• Manage and oversee multiple clinical study sites across one or more clinical projects.
• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure the safety, rights, and well-being of study participants at assigned sites.
• Monitor compliance with study protocols, GCP, and regulatory requirements.
• Review and verify clinical data for accuracy, completeness, and quality.
• Support patient recruitment and retention at study sites.
• Identify, elevate, and help resolve study-related issues and CAPAs when required.
• Maintain ISF and essential study documentation.

Connaissances

Site monitoring

English fluency

Stakeholder management

Organizational skills

Travel readiness

Formation

BSc/MSc Life Sciences

Outils

MS Office

Description du poste

We are looking for an experienced Senior Clinical Research Associate (CRA) to support clinical studies within a dynamic MedTech environment. In this role, you will be responsible for managing and monitoring clinical trial activities across multiple study sites, ensuring compliance with study protocols, regulatory requirements, and quality standards.

As a key member of the Clinical Operations team, you will act as the primary liaison between study sites and internal stakeholders, driving study performance and supporting the delivery of high-quality clinical data.

Responsibilities

• Manage and oversee multiple clinical study sites across one or more clinical projects.
• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure the safety, rights, and well-being of study participants at assigned sites.
• Monitor compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Review and verify clinical data to ensure accuracy, completeness, and quality.
• Support patient recruitment and retention activities at study sites.
• Identify, elevate, and help resolve study-related issues, including implementation of corrective and preventive actions (CAPAs) when required.
• Maintain oversight of Investigator Site Files (ISF) and other essential study documentation.
• Build and maintain strong working relationships with investigators, study coordinators, ethics committees, and other stakeholders.
• Contribute to investigator meetings, study training activities, and process improvement initiatives.
• Provide regular updates on site status, risks, and study progress to the clinical study team.

Profile

• Bachelor's or Master's degree in Life Sciences, Biological Sciences, Nursing, Pharmacy, Biomedical Sciences, or a related field.
• Minimum of 4 years of recent site monitoring experience as a Clinical Research Associate.
• Previous experience in clinical research is required.
• Experience monitoring Medical Device or Combination Product studies is strongly preferred.
• Solid understanding of ICH-GCP guidelines and applicable clinical research regulations.
• Strong communication, stakeholder management, and relationship-building skills.
• Excellent organizational skills and ability to manage multiple priorities simultaneously.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Relevant certifications such as CCRA, RAC, or similar are considered an asset.
• Clinical or medical background is a plus.
• Fluent in English, both written and spoken.
• Willingness to travel up to 80% of the time.

What We Offer

• A challenging opportunity within a leading and innovative MedTech organization.
• Involvement in cutting-edge clinical research projects with global impact.
• High level of autonomy and responsibility.
• Collaboration with multidisciplinary and international teams.
• Opportunities for professional development and career growth.
• Competitive compensation package with attractive benefits.
• Flexible and supportive working environment.