Remote Senior CRA - Phase I Monitoring & Oversight

Parexel; Austin (TX); Remote; USD 90,000 - 150,000; Full time

Job summary

Parexel in the United States seeks a Senior Clinical Research Associate to support monitoring and site management for sponsored studies, ensuring compliance with ICH GCP and regulatory requirements. This role involves on-site and remote activities with CTMS documentation and cross-functional collaboration.

You will oversee site visits, data integrity, safety reporting, and issue escalation, write monitoring reports, and contribute to inspection readiness.

Qualifications

• Bachelor's degree or equivalent required.
• Minimum of 5 years related Senior CRA experience.
• Strong knowledge of ICH GCP and regulatory requirements.

Responsibilities

• Perform site management and monitoring to ensure protocol and regulatory compliance.
• Conduct on-site and remote site visits and manage CTMS documentation.
• Review site data, ensure ALCOA data integrity, and address issues.
• Prepare and submit monitoring reports and study communications timely.
• Support inspection readiness and collaboration with cross-functional teams.

Skills

Communication skills

Analytical skills

Critical thinking

Time management

Education

Bachelor's degree

Tools

Microsoft Office

EDC

CTMS

Data repositories

Job description

Parexel in the United States seeks a Senior Clinical Research Associate to support monitoring and site management for sponsored studies, ensuring compliance with ICH GCP and regulatory requirements. This role involves on-site and remote activities with CTMS documentation and cross-functional collaboration.

You will oversee site visits, data integrity, safety reporting, and issue escalation, write monitoring reports, and contribute to inspection readiness.