Clinical Monitor, Clinical Research Associate, CRA
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Job Description
Clinical Research Associate monitoring German clinical trials for ClinSol’s contract research programs. Coordinating sites, regulatory submissions, study data, and investigator communication.
Responsibilities:
- Organise, coordinate, and monitor clinical trials in accordance with ICH-GCP guidelines and internal SOPs
- Recruit, select, and train investigators and study sites
- Conduct study initiation visits, routine monitoring visits (on-site / remote), and close-out visits at study sites throughout Germany
- Communicate with study sites and maintain written documentation
- Identify on-site issues and escalate them to the study sponsor
- Prepare and submit documentation to ethics committees and competent authorities
- Support correspondence activities
- Monitor schedules and deadlines
- Maintain study data in databases (Microsoft Access, Microsoft Excel)
- Support regulatory submission activities and maintain the Trial Master File (TMF)
Requirements:
- At least 1 year of experience as a Clinical Research Associate / Clinical Monitor
- Excellent knowledge of ICH-GCP and the German Medicinal Products Act (AMG)
- Excellent proficiency with standard PC applications, particularly Microsoft Office
- Good written and spoken English skills
- Excellent organisational skills, independence, flexibility, and reliability
- Strong team spirit, communication skills, and an open-minded approach
- Knowledge of monitoring oncology studies is an advantage
Benefits:
- Varied and interesting role in a growing company
- Secure employment
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