Overview
In this role you will support clinical trials in the Berlin/Leipzig/Dresden region, ensuring regulatory and protocol compliance across monitoring activities. You will work with site teams to safeguard data integrity, informed consent, and patient safety while coordinating with cross-functional partners. The role offers exposure to global monitoring standards and opportunities to contribute to audit readiness and study delivery. You will engage with investigators and sponsor teams to drive timely, high-quality trial execution.
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) ensuring ICH-GCP/GPP compliance.
- Evaluate site performance and escalate issues with actionable recommendations.
- Maintain knowledge of ICH/GCP and local regulations; adhere to SOPs and CMP/SMP.
- 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 accurate CRF data; drive query resolution to closure.
- Handle IP inventory, labeling, storage, and accountability per protocol.
- Reconcile ISF with TMF and ensure essential documents are archived per guidelines.
- Document activities using letters, logs, trip reports, and other required records.
- Support recruitment, retention and awareness strategies; enter observations into tracking systems.
- Manage project scope, budgets, timelines; coordinate site-level communications to meet objectives.
- Attend Investigator Meetings and sponsor meetings; participate in global monitoring and training.
- Assist with audit readiness and post-audit follow-up actions; maintain ongoing regulatory training.
Zentrale Anforderungen
- Bachelor in related field or RN; equivalent combination of education and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Fluency in German and English
- Strong computer skills and openness to new technologies
- Excellent communication, presentation and interpersonal skills
- Location in Berlin/Leipzig/Dresden area; willingness to travel for monitoring visits
- Strong communication and interpersonal skills
- Adaptability to changing priorities
- Problem-solving mindset
- Knowledge of ICH-GCP and regulatory requirements
- Experience with electronic data capture and data quality assurance
- Source Document Review and CRF data verification
Clinical Research Associate - Berlin/Leipzig/Dresden 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.
