Overview
As a Clinical Research Associate, you oversee site qualification, initiation, monitoring, and close-out to ensure protocol and regulatory compliance across Germany. You work with cross-functional teams to safeguard data integrity, patient safety, and trial quality, using remote and on-site monitoring as needed. Your role supports investigator sites, maintains documentation quality, and helps drive trial progress within budget and timeline. You will contribute to audit readiness and continuous process improvement in a fast-paced environment.
Leistungen / Benefits
- career development and progression
- supportive and engaged line management
- Total rewards program
- Total Self culture
- training in technical and therapeutic areas
Verantwortungsbereiche
- Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring ICH-GCP and GPP compliance
- Assess site performance and escalate issues with actionable plans
- Maintain knowledge of ICH/GCP, regulations, and SOPs
- Verify informed consent, protect subject confidentiality, and assess safety and data integrity factors
- Conduct source data review and ensure CRF accuracy; drive query resolution
- Manage IP inventory, reconciliation, and compliance with labeling and handling
- Review Investigator Site Files (ISF) and reconcile with TMF; ensure archiving per guidelines
- Document activities via letters, reports, logs per SOPs
- Support subject recruitment, retention, and awareness strategies; enter data into tracking systems
- Understand project scope, budgets, timelines; manage site-level communications and deliverables
- Prepare for and participate in Investigator Meetings and sponsor meetings; provide audit readiness guidance
- Maintain training and knowledge of regulations and SOPs; adapt to changing priorities
- Liaise with site personnel and cross-functional teams to ensure site training and compliance
Zentrale Anforderungen
- Bachelor’s degree or RN in related field or equivalent combination of education and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Previous monitoring experience in Germany
- Strong computer skills and ability to adapt to new technologies
- Excellent communication, presentation, and interpersonal skills
- Fluency in German and English
- Ability to travel for monitoring visits
- Excellent communication
- Interpersonal skills
- Adaptability
- ICH-GCP knowledge
- Regulatory compliance understanding
- Electronic data capture and data tracking systems
CRA single-sponsor in Germany Diabetes and Obesity in Darmstadt 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.
