Overview
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.
Leistungen / Benefits
- career development and progression
- supportive line management
- therapeutic area training
- inclusion and diversity culture
- total rewards program
Verantwortungsbereiche
- 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
Zentrale Anforderungen
- 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
Clinical Research Associate Risk-Based Monitoring in Krefeld Arbeitgeber: Syneos Health
Syneos Health ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Entwicklung seiner Mitarbeiter einsetzt und eine inklusive Unternehmenskultur fördert, in der jeder authentisch sein kann. Mit einem starken Fokus auf Karriereentwicklung, technische Schulungen und Anerkennung bietet das Unternehmen zahlreiche Möglichkeiten zur persönlichen und beruflichen Entfaltung. In Nordostdeutschland gelegen, profitieren Mitarbeiter von einem dynamischen Arbeitsumfeld, das Innovation und Zusammenarbeit fördert, um gemeinsam bedeutende Fortschritte im Gesundheitswesen zu erzielen.
