Overview
As a Clinical Research Associate, you will oversee site qualification, initiation, monitoring, and close-out activities to ensure regulatory and protocol compliance. You’ll work with cross-functional teams to protect patient safety and data integrity across trials, including real-world late-phase studies. The role blends on-site and remote monitoring, data review, and collaboration with investigators to drive study success. This opportunity offers growth within a global organization that values development and diverse perspectives.
Leistungen / Benefits
- Total Self culture
- career development and progression
- peer recognition
- total rewards program
Verantwortungsbereiche
- Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring GCP/ICH compliance
- Evaluate site performance and staff, escalating issues and proposing corrective actions
- Ensure informed consent processes and patient confidentiality are maintained
- Perform CMP/SMP tasks: source data review, CRF data verification, and query resolution
- Manage IP inventory, labeling, and dispensing per protocol; ensure compliance with IP handling
- Review ISF and TMF for accuracy and archiving requirements
- Support patient recruitment and retention; track observations and actions in tracking systems
- Collaborate with sponsors and sites to ensure timelines, budgets, and deliverables are met
- Prepare for Investigator Meetings and sponsor meetings; participate in training and audits
- Assist in audit readiness and follow-up actions; adapt to project changes and priorities
- Provide site-level training and ensure compliance with local requirements for studies
- Contribute to real-world late-phase study design and data collection
- Liaise with sponsor affiliates, medical science liaisons, and local country staff
Zentrale Anforderungen
- Bachelor’s degree in related field or RN; equivalent combinations considered
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Strong computer skills and ability to adopt new technologies
- Excellent communication, presentation, and interpersonal skills
- Willingness to travel up to 75%
- Experience with data capture, source data verification, and ISF/TMF processes (preferred)
- Excellent communication and interpersonal skills
- Adaptability to changing priorities
- Collaborative mindset and team orientation
- Knowledge of GCP/ICH guidelines
- Experience with electronic data capture and CRF data entry
- Source Document Review and query resolution
CRA – Future Roles (Germany) in Münster 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.
