Overview
As a CRA for a single sponsor partnership in Germany, you will oversee site qualification, initiation, monitoring, and close-out visits to ensure regulatory and protocol compliance. You will work with cross-functional teams to assess site performance, protect patient safety, and support data integrity through remote and on-site activities. You will contribute to audit readiness and site training, helping to deliver high-quality clinical trials. This role offers impact in advancing regulatory-compliant trials within a global organization dedicated to bringing therapies to patients faster.
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) with regulatory, ICH-GCP and GPP compliance
- Evaluate site performance and provide actionable recommendations; escalate issues to project team and implement action plans
- Maintain knowledge of ICH/GCP guidelines, regulations, and SOPs/processes
- Verify informed consent procedures and protect subject confidentiality
- Conduct Source Document Review and ensure accurate CRF data; drive query resolution to closure
- Manage IP inventory, reconciliation, and ensure proper IP labeling, import, release/return
- Reconcile ISF with TMF and ensure archiving of essential documents
- Document activities via required project documents and support recruitment and retention strategies
- Understand project scope, budgets, timelines; manage site-level communication to meet objectives
- Prepare for and attend Investigator Meetings and sponsor meetings; participate in global monitoring and training sessions
- Provide guidance towards audit readiness and support follow-up actions
- Maintain training and knowledge of regulatory requirements and SOPs
- Ensure site staff training and compliance with requirements
- Prepare for audits and follow-up actions
Zentrale Anforderungen
- Bachelor’s degree or RN in related field or equivalent
- Knowledge of GCP/ICH guidelines and regulatory requirements
- Previous monitoring experience in Germany
- Good computer skills and adaptability to new technologies
- Fluency in German and English
- Excellent communication, presentation and interpersonal skills
- Ability to travel for monitoring visits within Germany
- Excellent communication
- Interpersonal skills
- Adaptability to changing priorities
- GCP/ICH knowledge
- IP inventory and handling
- Source data review and CRF data verification
CRA South-West Germany in Münster 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.
