Klinische Auftragsforschung und Medical Education
Clinical Monitor, Clinical Research Associate, CRA
Location
Germany
Posted
1 day ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Monitor, Clinical Research Associate, CRA
ClinSol GmbH & Co. KG
• 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)
Job 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
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