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As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing :

• The Sr. Clinical Research Associate will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
• Applies knowledge of ICON’s policies and procedures
• Demonstrates excellent written and oral communication
• Demonstrates excellent knowledge of ICH / GCP
• Displays ability to manage investigative sites to facilitate trial deliverables
• Demonstrates ability to escalate issues appropriately
• Conducts monitoring to confirm subject safety and data integrity
• Describes and demonstrates the principals of IP accountability
• Identifies scientific misconduct at the site level
• Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS / IWRS and Electronic Data Capture platforms
• Mentors CRAs new to the position or company
• Serves as an observation visit leader
• Conducts monitoring evaluation visits
• Assists team lead in the development of trial tools or documents
• Assists with CTM tasks
• Participates in the development of process changes / improvements
• Presents at client meetings / Investigator meetings
• Provides training to trial teams

You are :

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Read, write and speak fluent English; fluent in host country language required.
• 2 years of experience supporting clinical trials including 1 year of on-site monitoring experience (for CRA2); 4 years of experience supporting clinical trials including 3 years of on-site monitoring experience (for CRA3)
• Ability to travel for approximately 10 site visits each month
• Proven success monitoring fast paced trials with quick turnaround times for database lock
• High proficiency with Microsoft Office and company collaboration applications
• Advanced skill in utilization of applicable clinical systems
• Experience in monitoring all trial components (PSSV to COV) is preferred