Clinical Research Associate

hace 3 días


Ciudad de México, Ciudad de México Icon Plc A tiempo completo

Job Summary
Clinical Research Associate - Site Monitoring

Icon Plc is seeking a highly motivated Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring the progress of clinical studies at investigative sites. Your primary responsibilities will include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.



About the Role
This is an exciting opportunity to work with a leading clinical research organization and contribute to the success of our clinical trials. As a Clinical Research Associate, you will have the opportunity to work independently, with minimal supervision, and make a significant impact on the success of our studies.



Key Responsibilities
• Qualify potential investigative sites for clinical trials
• Initiate clinical trials and maintain study files
• Provide instructions to site personnel and study close out
• Verify the protection of study participants and ensure the integrity of clinical data
• Manage essential documents and assist with resolution of investigational site/data queries
• Perform key risk assessment and management responsibilities throughout the project



Requirements
• 3 years of experience supporting clinical trials, including 3 years of on-site monitoring experience
• In-depth knowledge of the drug development process
• In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements
• Sound knowledge of applicable policies and procedures, SOPs, work instructions, and other guidance documents
• Good spoken and written communication skills; good presentation skills
• Strong interpersonal, collaboration, and time management skills
• Excellent skill in the utilization of applicable clinical systems
• Excellent critical thinking skills; excellent organizational skills
• Ability to focus on detail for extended periods of time; high attention to accuracy
• Ability to travel extensively



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