Úvod » CRA / Clinical Research Associate 2
CRA / Clinical Research Associate 2
For our client, a successful international original pharmaceutical company, we are looking for candidates for the position „CRA/Clinical Research Associate 2“
Jobs desription and main responsibilities:
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Performs site evaluation, training, monitoring and closure visits and applies risk-based monitoring.
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Closely interacts with project team, local start-up team, contract group, and Line Manager.
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Maintains Trial Master File (eTMF) and is responsible for its accuracy and completeness.
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Closely cooperates with Start-up Specialists regarding EC and RA submissions and may assist with ICF creation or update.
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Is responsible for accurate and timely completion of reports, issues / deviation reporting and resolution.
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Participates in various work groups and performs other assigned tasks.
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Manages and supports clinical trial sites and ensures that clinical trials are conducted in accordance with protocol and appropriate quality standards, applicable regulations and study guidance.
Requirements:
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Master´s degree in life sciences, pharmacy or medicine
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Previous experience on CRA position (on-site) at least 2 years as minimum
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Excellent knowledge of ICF-GCP
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Native Czech (or Slovak) speaker and advanced level of English (speaking and writing) are a must
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PC skills (MS Excel, PowerPoint, Word, Outlook)
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Experiences in using study systems (eCRF, IVRS, ePRO, CTMS)
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Strong organizational skills, flexibility, detail-oriented
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Drivers licence and ability to travel up to 50% of time, including overnight travel
We can offer:
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Background of successful international company
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Professional and friendly team
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Mobile, notebook
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Very good salary
Location: Prague
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