Clinical Research Associate-Freelance

• Performing data verification of source documents;
• Conducting site visits, including pre-study, initiation, monitoring, and termination;
• Confirming adherence to all FDA, ICH-GCP, and local regulations;
• Ensuring implementation and compliance with FDA, and ICH-GCP guidelines
• Participating in budget negotiation and follow-up where applicable
• Assisting with data validation and query resolution
• Mentoring junior team members as required
• Ensuring the completion and collection of regulatory documents

• A minimum of 3 years of oncology experience as a CRA, Clinical Research Coordinator, and/or Research Nurse;
• A minimum of 1 year of monitoring experience in an early-phase clinical trial;
• Experience in solid tumor trials, including breast, lung, gastric, ovarian, and/or pancreatic cancer, is preferred;
• Fluent English required; French is desirable
• Experience monitoring in phase I trials will be value
• Completion of a science-related Bachelor’s degree
• Excellent knowledge of medical terminology and clinical monitoring process
• Strong ICH-GCPs knowledge
• Experience with clinical trial information systems
• Ability to travel up to 60% on average
• Must be legally authorized to work in the country

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