CRA (Paris, Lyon & Nantes)

• Performs and coordinates all aspects of the clinical monitoring and site management process in compliance with the Regulatory approved Protocol and Monitoring Plan.
• Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation.
• Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
• Develops collaborative relationships with investigational sites.
• Acts as a site Manager and processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
• Ensures audit / Inspection readiness.
• Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Your Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Valid driver's license
• Effective clinical monitoring skills with at least 1 year of monitoring experience
• Effective oral and written communication skills in French and English with the ability to communicate optimally with medical personnel and colleagues.
• Ability to travel and perform 8 days on Site per month on average.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
• Ability to handle Risk Based Monitoring concepts and processes.
• Strong attention to detail and time management skills
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good presentation skills

*Please submit your CV in English

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