Clinical Research Associate (Contract)

4D Molecular Therapeutics

1d • 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 Unmasked Clinical Research Associate (uIHCRA) to support the Company’s clinical trial activities. This position reports to the Unmasked Clinical Trial Manager, 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 uIHCRA 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 on the unmasked side
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred
• 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
• Willingness to travel as business needs demand (<15% anticipated)

Nice To Haves

• Experience supporting Phase 3 clinical trials
• Ophthalmology experience
• Experience with Veeva Vault systems

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

Benefits

• 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level