Clinical Research Associate (Contract)

4D Molecular Therapeutics

5h•Onsite

About The Position

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. 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.

Requirements

A. or B.S. degree required
Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment
Working knowledge of clinical trial operations and ICH GCP guidelines
Experience with TMF/eTMF systems
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
Willingness to travel as business needs demand (<5% anticipated)

Nice To Haves

Experience supporting Phase 3 clinical trials preferred
Ophthalmology Preferred
Veeva Vault preferred

Responsibilities

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
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
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
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
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
Support ad hoc Clinical Operations projects as assigned
Willingness to travel as trial needs demand (<5% 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