Overview
As a Clinical Research Associate, you oversee site performance to ensure regulatory and protocol compliance across Austria. You work with site teams to assess processes, support data quality, and manage communication to keep trials on track. You’ll apply GCP knowledge and risk-based monitoring to protect subjects and data integrity. This role offers exposure to global trials and collaboration within a diverse, patient-focused organization.
Leistungen / Benefits
- career development and progression
- Total Self culture and diversity commitment
- peer recognition
- training opportunities
- competitive rewards program
- supportive line management
Verantwortungsbereiche
- Qualify, initiate, monitor, manage, and close out trial sites (on-site or remote) in line with ICH-GCP and GPP requirements
- Evaluate site performance, escalate issues, and develop corrective action plans
- Ensure informed consent, confidentiality, and patient safety considerations are upheld
- Conduct source data verification, data queries, and EDC/completion reviews per CMP/SMP
- Manage IP inventory, labeling, and dispensing per protocol with GMP considerations
- Reconcile ISF and TMF, archive essential documents per local regulations
- Support recruitment, retention, and awareness strategies; track observations and actions in tracking systems
- Coordinate site training, investigator meetings, and sponsor meetings; participate in audits and prepare for audit readiness
- Ensure training and SOP compliance; adapt to shifting priorities to meet project timelines
- Travel for monitoring visits within Austria as required
Zentrale Anforderungen
- Bachelor’s degree or RN in a related field
- Knowledge of GCP/ICH guidelines and regulatory requirements
- Previous monitoring experience in Austria
- Strong computer skills and ability to adapt to new technologies
- Fluency in German and English
- Excellent communication, presentation and interpersonal skills
- Ability to travel as required for monitoring visits in Austria
- communication
- presentation
- interpersonal skills
- ICH-GCP knowledge
- GPP knowledge
- Source Data Verification (SDV)
Clinical Research Associate - Autria 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.
