In-House CRA — Phase 3 Clinical Trials (Contract)

Remote Genie; Northern (KY); Hybrid; USD 83,000 - 96,000; Full time

Job summary

4D Molecular Therapeutics seeks a detail-oriented In-House Clinical Research Associate (IHCRA) to support a Phase 3 trial. You will liaise with sites, CROs, and internal teams to ensure regulatory compliance and data quality.

This contract role demands strong communication, organization, and the ability to manage multiple priorities in a fast-paced biotech environment. Travel is expected (<5%).

Qualifications

• Ophthalmology experience preferred.
• Experience with TMF/eTMF systems (Veeva Vault preferred).
• Working knowledge of ICH GCP guidelines and clinical trial operations.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Strong organizational skills and ability to manage multiple priorities.

Responsibilities

• Support study startup, conduct, and close-out phases for Phase 3 trials.
• Serve as primary contact for sites and CRO monitors; communicate updates and resolve issues.
• Maintain study status reports and TMF/eTMF documentation.
• Ensure regulatory and TMF compliance; support inspections and audits.
• Coordinate meetings and prepare materials; manage action item logs.

Skills

Ophthalmology knowledge

TMF/eTMF systems

Microsoft Office

Communication skills

Education

B.S. or equivalent

Tools

Veeva Vault

Job description

4D Molecular Therapeutics seeks a detail-oriented In-House Clinical Research Associate (IHCRA) to support a Phase 3 trial. You will liaise with sites, CROs, and internal teams to ensure regulatory compliance and data quality.

This contract role demands strong communication, organization, and the ability to manage multiple priorities in a fast-paced biotech environment. Travel is expected (<5%).