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 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 (Apply To This Job
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 (Apply To This Job