Overview
In this role, you will monitor clinical sites to ensure regulatory and protocol adherence, overseeing data integrity and patient safety. You will collaborate with cross-functional teams across Austria and Germany, applying GCP/ICh guidance and SOPs. You’ll manage site activities, data capture and IP-related tasks, while supporting recruitment and audit readiness. This position offers exposure to global clinical monitoring practices within a mission-driven environment that values collaboration and continuous development.
Leistungen / Benefits
- career development and progression
- supportive line management
- technical and therapeutic area training
- peer recognition
- total rewards program
- Total Self culture
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote)
- Assess site processes, conduct Source Data Review, ensure accurate CRF data and timely query resolution
- Manage IP inventory, labeling, dispensing in compliance with protocol and GCP/local regs
- Reconcile ISF with TMF and ensure archival of essential documents
- Prepare and maintain project documentation (letters, trip reports, logs) and support recruitment/awareness strategies
- Attend Investigator Meetings and sponsor meetings; provide site-level audit readiness guidance
- Track observations and action items in tracking systems; ensure training and compliance of site staff
- Understand project scope, budgets, timelines and adapt to changing priorities
- Coordinate with primary site personnel or Central Monitoring Associate as needed
- Ensure training on applicable requirements across sites and projects
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 Germany
- Good computer skills and willingness to adopt new technologies
- Fluency in German and English
- Excellent communication, presentation and interpersonal skills
- Ability to travel for monitoring visits in Austria
- excellent communication
- presentation skills
- interpersonal skills
- EDC systems and electronic data capture
- data review and query resolution
- IP inventory and handling
CRA Germany in Köln 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.
