Clinical Monitor, Clinical Research Associate, CRA

🔥 8 minutes ago

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ClinSol GmbH & Co. KG

WebsiteLinkedInAll Job Openings

11 - 50 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📚 Education

Healthcare Insurance • Pharmaceuticals • Education

ClinSol GmbH & Co. KG is a company focused on providing digital medical education and resources specifically for healthcare professionals in the fields of oncology, immunology, and endocrinology. They offer a variety of tools, including informative medical apps, podcasts, and congress reports to help healthcare professionals stay informed about the latest developments, treatment guidelines, and research in their respective areas. Their platforms aim to facilitate knowledge exchange and professional development, ensuring users have access to the most current medical information.

📋 Description

• Organization, coordination and monitoring of clinical studies in accordance with ICH and GCP guidelines and internal SOPs • Recruitment, selection and training of investigators and study sites • Conducting site initiation visits, routine monitoring (on-site / remote) and close-out visits at study sites across Germany, including site communication and written documentation • Identifying on-site issues and escalating them to the study sponsor • Preparation and submission of documents to ethics committees and federal authorities, and support with correspondence • Tracking appointments and deadlines • Maintaining study data in databases (Access, Excel) • Support with submission activities / maintenance of the Trial Master File (TMF)

🎯 Requirements

• Minimum 1 year of experience as a Clinical Monitor • Very good knowledge of ICH-GCP and the German Medicinal Products Act (AMG) • Strong PC skills (MS Office) • Good command of English, both written and spoken • Excellent organizational skills, independence, flexibility, reliability • Strong team spirit, communication skills and openness • Ideally, experience monitoring oncology studies

🏖️ Benefits

• Varied and interesting work in a growing company • Secure workplace