Overview
As a Clinical Research Associate at Syneos Health, you will monitor sites for regulatory and protocol compliance within a single sponsor program in Austria. You will work with site teams to safeguard patient safety and data integrity while ensuring trial quality and timelines. The role blends on-site and remote monitoring to support efficient, compliant study execution. You will contribute to audit readiness and collaborate with cross-functional partners to advance the sponsor’s clinical program.
Leistungen / Benefits
- Total Self culture
- career development and progression
- peer recognition
- total rewards program
Verantwortungsbereiche
- Perform site qualification, initiation, monitoring, management, and close-out activities (on-site or remote) ensuring ICH-GCP/GPP compliance and protocol adherence
- Assess site performance and provide actionable recommendations; escalate serious issues to the project team
- Maintain knowledge of ICH/GCP guidelines, regulations, and SOPs/processes
- Verify informed consent processes and protect subject confidentiality
- Assess factors affecting subject safety and data integrity (protocol deviations, pharmacovigilance)
- Conduct source document review and ensure accuracy of CRF data; drive query resolution to closure
- Support IP inventory, reconciliation, and handling per protocol; ensure proper labelling and release
- Review ISF and TMF for accuracy; ensure archiving per guidelines
- Document activities through letters, trip reports, logs; track observations and actions in systems
- Support subject recruitment, retention, and awareness strategies; provide project-level training as required
- Understand project scope, budgets, timelines; manage site-level communications to meet objectives
- Attend Investigator Meetings and sponsor meetings; contribute to audit readiness and follow-up actions
- Maintain ongoing training and regulatory knowledge per requirements
Zentrale Anforderungen
- Bachelor’s degree or RN in a related field (or equivalent)
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Previous monitoring experience in Austria
- Good computer skills and adaptability to new technologies
- Fluency in German and English
- Excellent communication, presentation, and interpersonal skills
- Willingness to travel for monitoring visits in Austria
- Excellent communication and interpersonal skills
- Adaptability and ability to manage changing priorities
- Collaborative and proactive problem-solving approach
- GCP/ICH knowledge
- Source data verification and query resolution
- Electronic data capture processes
Clinical Resarch Associate single-sponsor 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.
