Senior Clinical Research Associate - Site Leader (Remote)

Parexel; Frankfort (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate to act as the primary site contact and site manager across all study phases. You will oversee site relationships, monitor activities for compliance with ICH-GCP, and collaborate with sponsor teams to ensure Site Ready status.

Key responsibilities include site visits, regulatory documentation, data quality oversight, and mentoring junior CRAs. This role requires significant travel (65–75% of time) and strong cross-functional communication.

Qualifications

• Minimum 4 years of direct site management experience in clinical monitoring.
• Solid knowledge of ICH-GCP and local regulatory requirements.
• Ability to travel 65–75% of working time domestically and internationally.
• Strong communication and mentoring capabilities.
• Experience in regulatory documentation and site visits.

Responsibilities

• Act as primary site contact and site manager across all study phases.
• Monitor site performance, recruitment, and protocol adherence.
• Ensure regulatory documentation is complete and compliant.
• Coordinate with sponsor teams to achieve Site Ready status.
• Lead site visits, generate reports, and track corrective actions.
• Mentor junior CRAs and support audit/inspection activities.

Skills

Site management

ICH-GCP knowledge

Mentoring

Data review

Communication

Travel readiness

Education

Bachelor's degree

Tools

MS Office

Job description

Parexel is seeking a Senior Clinical Research Associate to act as the primary site contact and site manager across all study phases. You will oversee site relationships, monitor activities for compliance with ICH-GCP, and collaborate with sponsor teams to ensure Site Ready status.

Key responsibilities include site visits, regulatory documentation, data quality oversight, and mentoring junior CRAs. This role requires significant travel (65–75% of time) and strong cross-functional communication.