Clinical Research Associate II - Home Based (m/w/d)

About the role

IQVIA Biotech, a division focused on smaller biotech and emerging biopharma clients, is looking for a Clinical Research Associate II to join its EU Clinical Monitoring team, which provides CRA, clinical lead and management oversight for global clinical studies. This is a home-based position in Belgium.

Key responsibilities

• Conduct site qualification, initiation, monitoring and close-out visits according to study protocols, GCP, ICH guidelines and regulatory requirements.
• Ensure sites maintain high standards of patient safety, data integrity, protocol compliance and study quality.
• Build and maintain relationships with investigators and site personnel, giving guidance, training and support.
• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution and site performance metrics.
• Help sites implement and optimise patient recruitment and retention strategies.
• Maintain accurate, inspection-ready documentation such as Investigator Site Files, Trial Master Files, monitoring reports and follow-up communications.
• Identify and escalate study risks, site issues and quality concerns, and partner with cross-functional teams on study execution.
• Mentor junior team members through coaching, training and co-monitoring, and contribute to continuous improvement and site financial activities.

Required profile

• University degree in a scientific discipline or health care.
• At least 18 months of independent, on-site monitoring experience as a CRA in a CRO or pharmaceutical environment.
• Excellent written and spoken Dutch, French and English.
• Organisational and problem-solving skills, and strong interpersonal and cross-cultural communication skills.
• A collaborative mindset for working with global teams, project managers and local study coordinators.

Required skills

• Good knowledge of and ability to apply GCP and ICH guidelines.
• Site monitoring and study documentation.