Clinical Research Associate (Contract)

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 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.  Role requires extensive experience in unmasked clinical settings. 

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.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• 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

Monitoring Oversight

• 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

Tracking & Study Oversight

• 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

Regulatory Documentation & TMF Management

• 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

Study Communications & Meetings

• 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

Additional Responsibilities

• 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