Clinical Research Associate

EPM Scientific; Brussel Hoofdstad; Sur place; EUR 42 000 - 65 000; Plein temps

Résumé du poste

EPM Scientific, partnered with a leading Medical Device organisation in Europe, is seeking a Clinical Research Associate to oversee clinical study sites and ensure high-quality data collection. You will monitor sites, ensure regulatory compliance, and support patient recruitment while traveling up to 80% across assigned sites.

Start date Jan 2027; 12-month full-time contract with potential extension. The ideal candidate holds a Life Sciences degree and at least 2 years of monitoring experience

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Biological Sciences, or related field.
• At least 2 years of monitoring experience in clinical trials.
• Experience with medical device studies or device-focused trials preferred.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsabilités

• Oversee assigned clinical study sites and act as primary contact for site personnel.
• Conduct site qualification, initiation, monitoring, and close-out visits per protocol and GCP.
• Ensure subject safety and high-quality data collection throughout the study.
• Maintain Investigator Site Files and essential documents for inspection readiness.
• Support patient recruitment/retention and address operational challenges.
• Collaborate with investigators, ethics committees, vendors and internal teams.

Connaissances

Organisational skills

Communication

Problem solving

Remote work adaptability

Formation

Bachelor’s degree in Life Sciences or related

Outils

Microsoft Office

Clinical trial documentation systems

Description du poste

EPM Scientific are currently partnered with a leading Medical Device organisation conducting international clinical research programmes across Europe. They are seeking a Clinical Research Associate to support ongoing and upcoming clinical studies. This individual will play a critical role in overseeing clinical study sites, ensuring high-quality data collection, maintaining regulatory compliance, and acting as the primary liaison between study sites and the wider clinical study team. See a summary of the role below:

Role Overview:

• Start date: January 2027
• Contract Type: Full-Time, 12 Month initial contract (possibility for extension)
• Project: Medical Device Clinical Studies / Clinical Site Monitoring

Key Responsibilities:

• Manage assigned clinical study sites across one or multiple clinical projects, serving as the primary point of contact for site personnel.
• Conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols, GCP guidelines, and applicable regulations.
• Ensure subject safety, protocol compliance, and the collection of high-quality clinical data throughout the study lifecycle.
• Review and maintain Investigator Site Files and essential documentation to ensure inspection readiness and regulatory compliance.
• Support patient recruitment and retention activities and work collaboratively with sites to address operational challenges.
• Collaborate with investigators, ethics committees, vendors, and internal cross-functional teams to ensure successful study execution and timely delivery of project milestones.

Requirements:

• Bachelor's degree in Life Sciences, Nursing, Biological Sciences, or a related scientific discipline.
• Previous clinical research experience with at least 2 years of monitoring experience within clinical trials.
• Experience monitoring medical device studies or equivalent clinical research experience highly preferred.
• Strong understanding of ICH-GCP, clinical trial regulations, and medical device clinical research requirements.
• Excellent organisational skills with the ability to manage multiple study sites, priorities, and deadlines simultaneously.
• Strong communication, stakeholder management, and problem-solving skills with the ability to work independently in a remote environment.
• Proficiency with Microsoft Office applications and clinical trial documentation systems.
• Willingness and ability to travel extensively (up to 80%) across assigned study sites.