Phase I Senior CRA — Site Monitoring & Trials Lead

Fortrea; North Carolina; On-site; USD 100,000 - 130,000; Full time

Job summary

Fortrea is seeking a Senior Clinical Research Associate with 3+ years of Clinical Monitoring experience, including Phase I. The role requires travel of 40-50% overnight and involves monitoring, site management, and data integrity across study sites in the U.S.

You will ensure regulatory compliance, data quality, and patient safety in a fast-paced environment. Responsibilities include site visits, monitoring, SAE processing, and collaboration with vendors.

Qualifications

• 3+ years of Clinical Monitoring experience with Phase I exposure
• Must reside in the United States and be willing to travel 40-50% overnight
• Ability to maintain high standards of data integrity and patient safety
• Experience with site management, regulatory compliance, and SAE reporting

Responsibilities

• Monitor study sites and conduct routine monitoring and site close-out
• Liaise with vendors and manage project plans and site initiation visits
• Ensure informed consent procedures and protocol adherence per regulatory requirements
• Review CRFs, query data, and ensure data integrity across systems
• Coordinate feasibility efforts and act as Local Project Coordinator as needed

Skills

Clinical Monitoring

Site Management

CRF Review

SAE Reporting

Training & Coaching

Local Project Coordination

Teamwork

Communication

Data Integrity

EDC / Electronic Data Capture

Education

University degree or allied health certification

Tools

EDC systems

Job description

Fortrea is seeking a Senior Clinical Research Associate with 3+ years of Clinical Monitoring experience, including Phase I. The role requires travel of 40-50% overnight and involves monitoring, site management, and data integrity across study sites in the U.S.

You will ensure regulatory compliance, data quality, and patient safety in a fast-paced environment. Responsibilities include site visits, monitoring, SAE processing, and collaboration with vendors.