Clinical Research

• Manage clinical sites for Phase I–IV studies from start-up through close-out
• Perform site identification, feasibility, pre-study evaluation, study start-up, site initiation, monitoring, patient recruitment and close-out activities
• Conduct clinical site management and monitoring in compliance with ICH-GCP, SOPs, local laws, regulations and study protocols
• Serve as primary contact for clinical sites throughout all study phases
• Arrange monitoring availability and maintain data-entry timelines
• Perform source data verification, remote data review and query resolution
• Develop site-specific recruitment, retention and follow-up plans
• Communicate with investigators and site staff regarding protocol conduct, recruitment, deviations, inspection readiness and site performance
• Identify, assess, escalate and resolve site performance and quality issues
• Prepare and collect essential documents for regulatory and IRB/EC submissions
• Facilitate site budget and contract negotiations and finalize clinical trial agreements
• Support investigator site audits and inspection activities
• Contribute best practices and participate in clinical operations improvement initiatives
• Coach and mentor colleagues
• Review systems and procedures and support study management and staff training as needed

Explore Clinical Research Associate – Site Director at Codera. Review requirements and application details.

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