Clinical Research Associate

About the company

Lycia Therapeutics

Biotechnology · 11 to 50 employees

What you'll do

• Site Management and Support: Assist with investigator recruitment, site selection activities, study startup, and close-out tasks. Provide ongoing operational support to investigative sites via phone and email.
• Document & Regulatory Tracking: Collect, review, and track essential regulatory documents and Investigator Site Files (ISF) to ensure audit and inspection readiness. Maintain the electronic Trial Master File (eTMF).
• Data and Query Management: Review data points and findings within Electronic Data Capture (EDC) systems. Write, track, and follow up on clinical data queries with site personnel.
• Remote Monitoring & Collaboration: Support traveling CRAs by conducting remote monitoring activities, tracking site key performance indicators (KPIs), and updating Clinical Trial Management Systems (CTMS).
• Compliance & Escalation: Ensure trial conduct aligns with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA/local regulations, and study-specific standard operating procedures (SOPs). Escalate site non-compliance or protocol deviations to Clinical Operations Management.
• Site Monitoring Visits: Conduct qualification, site initiation, interim monitoring, and close-out visits in person or via remote monitoring tools.
• Data Verification: Review source documents, medical records, and Case Report Forms (CRFs/EDC) to verify data accuracy, completeness, and integrity.
• Protocol & Regulatory Compliance: Ensure site staff adhere to the study protocol, ICH-GCP guidelines, FDA regulations, and standard operating procedures (SOPs).
• Issue Escalation: Identify, document, and track protocol deviations, adverse events, and data queries, working with site investigators to implement corrective and preventive actions (CAPA).
• Investigational Product (IP) Management: Check accountability, storage, dispensing, and return of investigational drugs or devices at study sites.
• Documentation & Reporting: Maintain comprehensive Trial Master File (TMF) documents and write detailed monitoring visit reports (trip reports) within required timelines.
• Site Support & Training: Train investigators and clinical research coordinators (CRCs) on study protocols, electronic data capture systems, and regulatory requirements.

What you need

• Education: Bachelor’s or advanced degree in a life science, nursing, pharmacy, or health-related field.
• Experience: 2+ years of clinical research experience (e.g., prior experience as a Clinical Research Coordinator, clinical data assistant, or junior CRA).
• Regulatory Knowledge: Deep understanding of ICH-GCP guidelines, FDA regulations, EU, and local ethics/IRB processes.
• Technical Skills: Proficiency with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and remote data review tools.
• Core Competencies: Strong attention to detail and problem-solving skills.
• Effective verbal and written communication.
• High level of organization and time management.
• Travel: Ability and willingness to travel to assigned clinical trial sites or co-monitoring (up to 30% travel)

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