[Remote] Clinical Research Associate (Contract)

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. Apply To This Job Apply To this Job