Clinical Research Associate (CRA) - Site Monitor - Lille, France
Corin, France

Corin is seeking a Clinical Research Associate (CRA) Site Monitor to manage assigned clinical studies monitoring activities in compliance with protocols, company SOPs and applicable regulations. The CRA Site Monitor is involved in all stages of the clinical study: initiating, monitoring and closing the study sites.

The position is home based, ideally near Lille France with travel to the CORIN France (Montbonnot) office on a quarterly / monthly basis as agreed with the line manager.

The key responsibilities for the CRA Site Monitor include the following activities:

• Develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and Follow-up visits compliance in accordance with the protocol.
• Identify, evaluate, report and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations.
• Write high quality and accurate visit reports and follow up with sites on outstanding items.

Requirements

The ideal Clinical Research Associate - Site Monitor will have a

• Degree in a Life Science subject or a Clinical Research field.
• More than two years experience in clinical research - site monitoring experience either with a healthcare company, Clinical Research Organisation (CRO). Experience in a medical device company is preferred.
• Understands and can apply knowledge of clinical study designs to study execution
• Advanced knowledge and experience with GCP/ICH, ISO 14155:2020
• Advanced knowledge of medical device directive (MDD) and regulation (MDR) and local requirements
• Good computer skills: good knowledge of Microsoft Office including MS Outlook, Word, Excel and Power Point
• Experience in data management would be preferred
• Good English speaking and written skills including writing documents in English.
• Strong communication skills as principal point of contact for investigator
• Excellent organizational skills with high attention to detail is required
• Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
• Strong computer skills (spreadsheets, word processing, etc) is required
• Strong presentation skills to internal professionals and external collaborators Demonstrated flexibility and adaptability
• Autonomy with proactive approach to learning and problem solving
• Ability to work from home and travel up to 70%, depending on study phase and specific needs of the assigned studies

Job Rewards and Benefits