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 2 years of monitoring experience in oncology trials
• Experience monitoring in early-phase trials will be valued.
• 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
• Bilingualism (English/Spanish) is required 

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Teamwork · Passion · Integrity · Innovation