Overview
As a Clinical Research Associate (CRA) in Austria, you will oversee site qualification, initiation, monitoring, and close-out to ensure regulatory and protocol compliance. You’ll assess site performance, support data integrity, and manage investigations and communications with study staff. This role combines remote and on-site duties within a global clinical monitoring framework. You contribute to audit readiness and collaborate with cross-functional teams to drive trial quality and patient safety. You work in a mission-driven environment focused on accelerating lab-to-life outcomes.
Leistungen / Benefits
- Total Self culture
- career development and progression
- supportive line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) with regulatory and protocol compliance
- Assess site performance and staff, provide actionable recommendations and escalate serious issues
- Maintain knowledge of ICH/GCP guidelines and applicable regulations; follow SOPs/processes
- Verify informed consent processes and protect subject confidentiality
- Conduct source data review and ensure accurate CRF data entry; drive query resolution to closure
- Manage IP inventory, storage, and labeling per protocol; ensure proper dispensation
- Reconcile ISF with TMF and ensure archival of essential documents
- Support recruitment, retention, and awareness strategies; update tracking systems
- Coordinate project scope, budgets, timelines; manage site-level communications to meet objectives
- Prepare for and attend Investigator Meetings and sponsor meetings; participate in training and audits
- Train site personnel on requirements and ensure compliance with trial procedures
- Maintain project documentation and support audit readiness
Zentrale Anforderungen
- Bachelor’s degree in related field or RN; equivalent combination of education and experience
- Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements
- Previous monitoring experience in Austria
- Good computer skills and ability to learn new technologies
- Fluency in German and English
- Excellent communication, presentation and interpersonal skills
- Ability to travel for monitoring visits within Austria
- strong communication skills
- collaborative mindset
- problem-solving abilities
- clinical monitoring and site management
- data entry and query resolution
- electronic data capture and IP handling
CRA Austria - single-client 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.
