Overview
As a CRA in the Heidelberg/Stuttgart region, you will ensure site performance and data integrity across sponsor-led trials. You will work closely with site teams to maintain regulatory and GCP compliance, manage monitoring activities, and support data quality and patient safety. You’ll navigate local regulations, perform site-based and remote monitoring, and contribute to audit readiness and trial execution. This role offers meaningful impact by accelerating clinical development and improving patient outcomes within a collaborative, globally respected organization.
Leistungen / Benefits
- career development and progression
- supportive line management
- peer recognition
- total rewards program
- Total Self culture
- global collaboration
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) ensuring regulatory and GCP/GPP compliance
- Assess site performance, issue action plans, escalate serious findings, and communicate with the project team
- Maintain knowledge of ICH/GCP and relevant regulations and company SOPs
- Verify informed consent accuracy and protect subject confidentiality
- Conduct Source Document Review and ensure CRF data accuracy; resolve queries within timelines
- Manage IP inventory, labeling, dispensing, reconciliation, and storage considerations
- Reconcile ISF with TMF; ensure archiving of essential documents per guidelines
- Document activities via letters, trip reports, logs; support recruitment and retention strategies
- Track project scope, budgets, timelines, and communication; adapt to shifting priorities
- Prepare for Investigator/ sponsor meetings and participate in global project/staff meetings
- Support audit readiness and follow-up actions; complete required trainings
- Maintain knowledge of regulatory guidelines and SOPs; adapt to project requirements
Zentrale Anforderungen
- Bachelor’s degree or RN in a 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
- Excellent communication, presentation, and interpersonal skills
- Location: Stuttgart/Heidelberg region
- Ability to travel up to 75% regularly
- communication
- interpersonal skills
- adaptability
- ICH/GCP knowledge
- regulatory compliance
- IP management and labeling
CRA Heidelberg/Stuttgart 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.
