Jobbeschreibung

Positionsnummer / Reference Number

PA1200107082019

Position / Job Title

Senior CRA/Co-Monitor - remote assignment

Aufgaben / Tasks

• Monitoring of clinical trials in accordance to ICH guidelines, GCP and local regulations
• Responsible for all monitoring activities from site selection to close out - Responsible for the timely delivery of study milestones (e. g. study startup, recruitment, database analyses, closeout)
• Mentoring and training junior staff and Clinical Research Associates
• Conducting co-monitoring visits
• Reviewing and authoring of the monitoring and recruitment plan
• Executing clinical trial protocols at clinical trial sites within the assigned regions
• Close collaborations with Clinical Operations Study Lead and study sites
• Documentation of monitoring activities following ICH-GCP and internal standards

Qualifikationen / Qualifications

• Scientific Bachelors’ degree in a relevant area
• 5-10 years of monitoring experience as CRA at the CRO or at the sponsor
• Indication specific expertise within oncology trial preferred
• Excellent communication and organizational skills
• Business fluent in English

Weitere Informationen / Further Information

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