[Remote] Clinical Research Associate (Contract)

Note: The job is a remote job and is open to candidates in USA. 4D Molecular Therapeutics is a leading late-stage biotechnology company focused on advancing disease-targeted therapeutics. They are seeking a motivated In-House Unmasked Clinical Research Associate to support clinical trial activities, including execution, site support, and regulatory compliance for a Phase 3 clinical trial.

Responsibilities

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary unmasked sponsor point of contact for unmasked clinical site staff in collaboration with CRO field unmasked CRAs/monitors
• Communicate directly with unmasked site staff and unmasked CRO partners to obtain updates, resolve issues, and support study timelines
• Support site initiation, ongoing site management, and site close-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues
• Support oversight of unmasked CRO monitoring activities
• Review unmasked monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Unmasked Clinical Trial Manager, Clinical Operations as appropriate
• Support inspection readiness and audit activities
• Maintain accurate tracking tools for assigned studies, including: Site start up and activation status, Initial IP supply and Ancillary supply, Site visit activities, IP Shipment status and delivery, Assist with preparation of study status reports and metrics
• Collect, review, and track site applicable SOPs
• Ensure timely filing of unmasked documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out
• Support the review of Quality Incidents and follow up activities
• Support organization and coordination of internal team meetings, and other study related meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders
• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (Apply tot his job

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