[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.ResponsibilitiesSupport study execution across start-up, conduct, and close-out phasesServe as a primary unmasked sponsor point of contact for unmasked clinical site staff in collaboration with CRO field unmasked CRAs/monitorsCommunicate directly with unmasked site staff and unmasked CRO partners to obtain updates, resolve issues, and support study timelinesSupport site initiation, ongoing site management, and site close-out activitiesAssist with identification, documentation, tracking, and follow-up of site issuesSupport oversight of unmasked CRO monitoring activitiesReview unmasked monitoring visit reports and follow up on action items and unresolved findingsTrack monitoring deliverables and escalate issues to the Unmasked Clinical Trial Manager, Clinical Operations as appropriateSupport inspection readiness and audit activitiesMaintain 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 metricsCollect, review, and track site applicable SOPsEnsure timely filing of unmasked documents in the TMF/eTMF in accordance with TMF plansPerform TMF quality control activities and support TMF audits and study close outSupport the review of Quality Incidents and follow up activitiesSupport organization and coordination of internal team meetings, and other study related meetingsPrepare meeting materials, take meeting minutes, and maintain action item logsSupport communication of study updates to internal stakeholdersSupport ad hoc Clinical Operations projects as assignedWillingness to travel as trial needs demand (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 timeSkillsA. or B.S. degree requiredMinimum of 4+ years of experience supporting clinical trials in a sponsor or CRO environment on the unmasked sideWorking knowledge of clinical trial operations and ICH GCP guidelinesExperience with TMF/eTMF systems (Veeva Vault preferred)Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)Strong organizational skills and attention to detailAbility to manage multiple priorities and meet deadlinesStrong interpersonal skills and ability to collaborate effectively with cross functional teams and external partnersExperience supporting Phase 3 clinical trials preferredOphthalmology PreferredCompany Overview4D 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.