Overview
In this CRA role, you monitor and ensure regulatory and protocol compliance across sponsor sites in Germany, with focus on data integrity and site performance. You will work closely with site teams and cross-functional colleagues to drive quality monitoring and risk-based approaches. This position supports remote and on-site monitoring, documentation, and site readiness to advance clinical trials. You join a global team aligned with Syneos Health’s mission to shorten the distance from lab to life and deliver impactful trials.
Leistungen / Benefits
- career development and progression
- supportive line management
- peer recognition
- total rewards program
- focus on Total Self culture
- global collaboration
Verantwortungsbereiche
- Perform site qualification, initiation, monitoring, management, and close-out visits (on-site or remote)
- Assess site processes, source documents, and data accuracy; drive query resolution
- Verify IP inventory, labeling, storage, and administration per protocol
- Maintain ICH-GCP/regulatory knowledge; ensure archiving of essential documents
- Prepare for Investigator Meetings and sponsor/clinical trainings
- Support subject recruitment, retention, and awareness strategies
- Ensure site staff training and compliance; act as liaison with study personnel
- Document activities through letters, reports, and logs; track observations and action items
- Manage project scope, budgets, timelines and site communications to meet objectives
- Contribute to audit readiness and post-audit follow-up actions
- Monitor data capture, IP reconciliation, and TMF/ISF consistency
- Utilize data review tools and EDC requirements to ensure data quality
Zentrale Anforderungen
- Bachelor’s degree or RN in related field or equivalent experience
- Knowledge of GCP/ICH guidelines and regulatory requirements
- Previous monitoring experience in Germany
- Strong computer skills and adaptability to new technologies
- Fluency in German and English
- Excellent communication, presentation and interpersonal skills
- Ability to travel in Germany and Switzerland for monitoring visits
- excellent communication
- interpersonal skills
- adaptability
- ICH-GCP knowledge
- regulatory compliance
- Source Document Review (SDR)
CRA Augsburg region 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.
