Clinical Research Associate (Contract)

Clinical Research Associate (Contract) 4D Molecular Therapeutics - 4.5 Emeryville, CA Job Details Contract $38 - $52 an hour 1 day ago Qualifications Meeting minutes Project reporting Document review (document control) Microsoft Excel Microsoft Outlook Bachelor of Science Ophthalmology Filing Mid-level ICH guidelines Bachelor's degree Data quality monitoring Research compliance clinical trial records management Organizational skills Quality control operations Research regulatory compliance 1 year Communication skills Regulatory compliance management Cross-functional communication Full Job Description Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY 4DMT

seeks a motivated and detail-oriented In-House Clinical Research Associate (IHCRA) to support the Company's clinical trial activities. This position reports to the Associate Director, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and close-out activities. The IHCRA will serve as a key liaison between 4DMT, clinical sites, and CRO partners, with a focus on site support, monitoring oversight, regulatory compliance, and data quality. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-quality work in a fast-paced, team-oriented environment.

MAJOR DUTIES & RESPONSIBILITIES

Clinical Trial Operations & Site Support Support study execution across start-up, conduct, and close-out phases Serve as a primary point of contact for assigned clinical sites and CRO field CRAs/monitors Communicate directly with sites and 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 Monitoring Oversight Support oversight of CRO monitoring activities Review monitoring visit reports and follow up on action items and unresolved findings Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate Support inspection readiness and audit activities Tracking & Study Oversight Maintain accurate tracking tools for assigned studies, including: Site start up and activation status Subject enrollment and visit status Essential document collection and TMF status Vendor reconciliation Assist with preparation of study status reports and metrics Regulatory Documentation & TMF Management Collect, review, and track site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements Ensure timely filing of documents in the TMF/eTMF in accordance with TMF plans Perform TMF quality control activities and support TMF audits and study close out Study Communications & Meetings Support organization and coordination of internal team meetings, investigator 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 Additional Responsibilities Support ad hoc Clinical Operations projects as assigned Willingness to travel as trial needs demand (