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[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 (<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 side • Working knowledge of clinical trial operations and ICH GCP guidelines • Experience with TMF/eTMF systems (Veeva Vault preferred) • Proficient in Microsoft Office Suite (Word, Excel, 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 • 4D Molecular Therapeutics 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. Apply To This Job
