Overview
As a Clinical Research Associate, you will oversee site qualification, initiation, monitoring, and close-out to ensure GCP/ICH compliance and high-quality data. You will work with cross-functional teams to safeguard subject safety and data integrity while supporting site processes and audits. This role combines on-site and remote monitoring across Austrian sites to drive study timelines and regulatory adherence. You will contribute to continuous process improvements and mentor junior staff, within Syneos Health’s mission to shorten the distance from lab to life.
Leistungen / Benefits
- Total Self culture
- career development and progression
- peer recognition
- total rewards program
- training and technical/therapeutic area development
- supportive line management
Verantwortungsbereiche
- Conduct site qualification, initiation, interim monitoring, management and close-out visits (on-site or remote) ensuring regulatory and protocol compliance.
- Evaluate site performance and staff, escalate issues, and develop action plans.
- Verify informed consent processes and protect patient confidentiality.
- Assess factors affecting subject safety and data integrity (protocol deviations, pharmacovigilance).
- Perform source data review and ensure accuracy/completeness of CRFs via source documents.
- Manage IP inventory, labeling, and reconciliation per protocol; ensure IP storage and security.
- Review ISF and TMF for accuracy; ensure archiving per guidelines.
- Document activities via letters, trip reports, logs, and SOP-compliant records.
- Support recruitment/retention strategies and track observations/activities.
- Understand project scope, budgets, and timelines; manage site communications to meet deliverables.
- Coordinate training/compliance for sites and project teams; may lead meetings.
- Assist audits preparation and implement post-audit actions.
- Provide mentorship or training to junior CRAs; potentially lead clinical operations tasks under supervision.
Zentrale Anforderungen
- Bachelor’s degree or RN in a related field or equivalent
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Previous monitoring experience in Austria
- Strong computer skills and adaptability to new technologies
- Excellent communication, presentation and interpersonal skills
- Fluency in German and English
- Ability to travel as required for monitoring visits
- Excellent communication
- Interpersonal skills
- Critical thinking
- Clinical Monitoring/Site Management
- Source Data Review and CRF validation
- Investigator Site File (ISF) and Trial Master File (TMF) reconciliation
CRA Autria 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.
