Clinical Research Associate Risk-Based Monitoring

As a Clinical Research Associate with Syneos Health in Germany, you will oversee site qualification, initiation, monitoring, and close-out to ensure regulatory and protocol compliance. You’ll assess site performance, support data integrity, and manage communications across study sites and the project team. You will work with cross-functional partners to maintain audit readiness and drive trial success, while adapting to changing priorities. This role offers the chance to impact patient progress through rigorous, quality-driven clinical monitoring.

• career development and progression
• supportive line management
• therapeutic area training
• inclusion and diversity culture
• total rewards program

• Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) per ICH-GCP/GPP and protocol
• Evaluate site performance and provide actionable recommendations; escalate serious issues
• Maintain knowledge of ICH/GCP and local regulations; ensure SOP compliance
• Verify informed consent processes and protect subject confidentiality
• Perform Source Document Review and ensure accurate CRF data entry; drive query resolution
• Manage IP inventory, handling, labeling, and compliance with study protocol
• Reconcile ISF and TMF; ensure archiving of essential documents
• Support recruitment, retention, and site-level awareness strategies; enter data into tracking systems
• Prepare for meetings and contribute to audit readiness; participate in training and project meetings

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Experience monitoring in Germany, preferably in oncology
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation and interpersonal skills
• Fluency in German and English
• Residence in north-east Germany
• Ability to travel up to 75% regularly

• clear communication
• interpersonal skills
• problem-solving
• ICH-GCP knowledge
• regulatory requirements understanding
• investigational product handling and IP labeling