Overview
In this role you support clinical trial sites to ensure regulatory and protocol compliance across a multi-sponsor program. You work with cross-functional teams to monitor data integrity, manage site activities, and drive quality through both remote and on-site oversight. You help prepare for audits, contribute to site recruitment and training, and ensure timelines and budgets are met. This position offers the chance to contribute to patient-focused trials within a global, agile team.
Leistungen / Benefits
- career development and progression
- supportive and engaged line management
- therapeutic area training
- peer recognition
- total rewards program
- inclusive culture
Verantwortungsbereiche
- Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) ensuring GCP, GPP, and protocol compliance
- Evaluate site performance and escalate issues with action plans
- Maintain knowledge of ICH/GCP and applicable regulations and SOPs
- Verify informed consent processes and protect subject confidentiality
- Conduct Source Document Review and CRF data verification; drive query resolution
- Manage IP inventory, reconciliation, and storage/security in line with protocol
- Reconcile ISF and TMF, ensure archiving of essential documents
- Support subject recruitment, retention, and awareness strategies
- Enter data into tracking systems and monitor observations and action items
- Understand project scope, budgets, timelines and manage site-level activities
- Act as liaison with study site personnel and support training/compliance
- Prepare for and attend Investigator Meetings and sponsor meetings
- Assist audit readiness and follow-up actions
- Complete required trainings and maintain regulatory knowledge
- Travel up to 75% as needed
- Monitor across DACH region as required
Zentrale Anforderungen
- Bachelor’s degree or RN in related field or equivalent experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- At least two years of monitoring experience
- Strong computer skills and willingness to adopt new technologies
- Excellent communication, presentation, and interpersonal skills
- Fluency in German and English
- Willingness to travel up to 75% and preferably located in north-east Germany
- Experience with remote monitoring and data capture processes
- communication skills
- interpersonal skills
- presentation skills
- ICH-GCP knowledge
- regulatory compliance
- electronic data capture understanding
CRA II - multi-sponsor (north-east Germany) in Heidelberg 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.
