Clinical Research Associate III (Senior)
Region: Flanders Region, Belgium (Hybrid – On-Site & Home Based)
Contract Type: Permanent
Hours: 40 hours per week/ Full time
Role Overview
We are seeking an experienced Clinical Research Associate (CRA) to join a leading medical device organisation, specialising in innovative solutions for neurovascular care. This role will focus on managing clinical activities at study sites, ensuring high-quality execution of medical device studies, and building strong relationships with site personnel and internal stakeholders. You will oversee site monitoring, performance, and compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
Key Responsibilities
Clinical Study Site Management
* Ensure subject safety and well-being at assigned study sites.
* Support operational execution of medical device clinical trials, ensuring accurate, high-quality data collection.
* Monitor and oversee site performance in alignment with project timelines.
* Resolve site issues effectively, implementing corrective and preventive actions where necessary.
* Maintain Investigator Site Files in compliance with regulations and company procedures.
* Support patient recruitment and retention strategies.
* Conduct on-site visits to ensure adherence to protocol and regulatory standards.
* Facilitate communication of key clinical data and events to relevant stakeholders.
* Support the organisation of investigator meetings and study-related training sessions.
* Act as a reliable source of accurate, up-to-date site status information.
* Contribute to the implementation of new clinical systems and processes.
* Liaise with investigators, ethics committees, vendors, and internal teams as needed.
Administrative & Compliance
* Adhere to all applicable laws, regulations, and internal compliance procedures.
* Provide additional administrative and operational support to Clinical Operations as required.
Requirements
* Bachelor’s degree in Life Sciences, Nursing, Biological Science, or related field (Master’s or PhD/MD/PharmD preferred).
* Minimum 4 years’ relevant clinical research experience, with strong, proven experience in medical device monitoring.
* Strong understanding of clinical research regulations, medical device standards, and applicable guidelines.
* Industry certifications such as CCRA, RAC, or CDE preferred.
* Clinical or medical background is an advantage.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Skills & Attributes
* Strong organisational skills and attention to detail.
* Ability to work independently and collaboratively in cross-functional teams.
* Excellent communication and stakeholder management abilities.
* Comfortable with hybrid working arrangements and regional travel.
What We Offer
* Competitive salary and benefits package.
* Opportunity to contribute to groundbreaking medical device innovations.
* A collaborative and inclusive working environment.