Clinical Research Associate
EPM ScientificEPM 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
- Location: Belgium
- Contract Type: Full-Time, 12 Month initial contract (possibility for extension)
- Language: English, Dutch
- 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.
If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.