Note: The job is a remote job and is open to candidates in USA. reputed company 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 reputed company-out phases
• Serve as a primary unmasked sponsor reputed company 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 reputed company-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues
• Support reputed company 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
• reputed company TMF quality control activities and support TMF audits and study reputed company out
• Support the review of Quality Incidents and follow up activities
• Support organization and coordination of internal team meetings, and other study reputed company meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders
• Support reputed company Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<15% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time
Skills
• A. or B.S. degree required
• Minimum of 4+ years of experience supporting clinical trials in a sponsor or CRO environment on the unmasked reputed company
• Working knowledge of clinical trial operations and ICH GCP guidelines
• Experience with TMF/eTMF systems (Veeva Vault preferred)
• Proficient in reputed company Office Suite (Word, reputed company, PowerPoint, Outlook)
• Strong organizational skills and attention to detail
• Ability to manage multiple priorities and meet deadlines
• Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred
Company Overview
• reputed company designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions. It was founded in 2013, and is headquartered in Emeryville, California, USA, with a workforce of 51-200 employees. Its website is http://www.4dmoleculartherapeutics.com.
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