Lycia Therapeutics

Clinical Research

• Assist with investigator recruitment, site selection, study startup, and close-out tasks
• Provide ongoing operational support to investigative sites via phone and email
• Collect, review, and track essential regulatory documents and Investigator Site Files
• Maintain the electronic Trial Master File (eTMF)
• Review data and findings in Electronic Data Capture systems
• Write, track, and follow up on clinical data queries with site personnel
• Support traveling CRAs through remote monitoring activities
• Track site key performance indicators and update Clinical Trial Management Systems
• Ensure trial conduct aligns with GCP, ICH guidelines, FDA/local regulations, and study-specific SOPs
• Escalate site non-compliance and protocol deviations to Clinical Operations Management
• Conduct qualification, site initiation, interim monitoring, and close-out visits in person or via remote monitoring tools
• Review source documents, medical records, and Case Report Forms to verify data accuracy, completeness, and integrity
• Identify, document, and track protocol deviations, adverse events, and data queries
• Work with site investigators to implement corrective and preventive actions
• Check investigational product accountability, storage, dispensing, and return
• Maintain comprehensive Trial Master File documents
• Write detailed monitoring visit reports within required timelines
• Train investigators and clinical research coordinators on study protocols, EDC systems, and regulatory requirements

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Clinical Research Associate