Research Analyst

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH-GCP, local regulations, and SOPs
• Perform feasibility, site identification, selection and evaluation; support site lists and recruitment targets
• Provide protocol and study training to assigned sites
• Conduct monitoring visits (pre-study, initiation, routine, closeout) and co-monitoring visits as required
• Complete monitoring visit reports per ICH-GCP and BeOne standards
• Manage sites and site performance: track regulatory submissions, recruitment, CRF completion, data query resolution
• Establish regular communication with sites and report progress, issues and proposed actions to Clinical Operations
• Ensure inspection readiness of the study and sites; facilitate SOVs, site audits and inspections
• Collaborate with Regional Clinical Operations Manager and study sites to meet study milestones (startup, recruitment, database analyses, closeout)
• Evaluate quality and integrity of site practices; escalate quality/GCP issues and propose CAPAs
• Support study start-up and provide local expertise; attend indication and CRA training as required

Clinical Research Associate

Job Level

Tech Stack

About the role

Requirements

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Clinical Trial Manager

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