Overview
As a CRA II for our multisponsor team in Germany, you oversee site performance and trial data integrity through monitoring and site management. You align with ICH-GCP, GPP and protocol requirements, liaising with site staff and project teams to resolve issues and keep study timelines on track. You cover remote and on-site activities, including IP handling, ISF/TMF reconciliation, and data verification, while contributing to audit readiness. This role supports patient safety and trial quality in a fast-paced, collaborative environment.
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote)
- Assess site performance and escalate issues with action plans
- Maintain knowledge of ICH/GCP and applicable regulations; follow SOPs
- Verify informed consent and protect patient confidentiality
- Conduct Source Document Review and ensure accurate CRF data entry
- Resolve data queries and drive timely closure
- Manage IP inventory, labeling, and adherence to protocol for dispensing
- Reconcile ISF and TMF, ensure archiving per guidelines
- Support recruitment/retention strategies and track observations in systems
- Prepare for/attend Investigator Meetings and sponsor meetings; participate in training
- Assist in audit readiness activities and post-audit follow-up
- Communicate with sites to ensure training and compliance
- Travel up to 75% as required and adapt to changing priorities
- Maintain tracking and reporting using available systems
Zentrale Anforderungen
- Bachelor’s degree or RN in a related field or equivalent
- Knowledge of GCP/ICH and relevant regulatory requirements
- Two years of monitoring experience
- Strong computer skills and adaptability to new technologies
- Excellent communication and interpersonal skills
- Fluency in German and English
- Location northeast Germany; travel within DACH region possible
- Ability to manage travel up to 75%
- communication
- interpersonal skills
- problem-solving
- ICH-GCP
- Source Data Review
- electronic data capture (EDC)
CRA II Germany - multisponsor 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.
