Clinical Research Associate

Key Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits in accordance with the approved scope of work and Good Clinical Practice (GCP)
• Perform on-site and remote monitoring of investigational sites, including source document verification and case report form review
• Track site performance, enrollment metrics, and protocol deviations; escalate issues as needed
• Maintain and reconcile the Trial Master File (TMF) to ensure inspection readiness
• Cook with investigator, site coordinators, and internal study teams to keep trial timelines on track
• Support regulatory document collection and IRB/EC submissions as needed
• Aid with vendor coordination (labs, IRT, imaging, etc.) as applicable to study needs

Qualifications

• Bachelor's degree in life sciences, nursing, public health, or a related field (or equivalent relevant experience)
• 2+ years of CRA or clinical research coordination experience in a pharma, biotech, or CRO setting
• Working knowledge of ICH-GCP and FDA regulatory requirements
• Experience with EDC systems, CTMS, and eTMF platforms
• Strong organizational skills and comfort managing multiple priorities in a fast-moving environment
• Willingness to travel to site visits as required