Senior Clinical Research Associate - Remote & Site Oversight

Parexel; Denver (CO); Remote; USD 100,000 - 150,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management activities for sponsored studies in compliance with ICH GCP and local regulations. The role involves on-site and remote visits, collaboration with study teams and investigator sites, and oversight of data and operational metrics.

Responsibilities include conducting site qualification/initiation/interim/close-out visits, maintaining regulator files, and ensuring timely safety reporting.

Qualifications

• Bachelor’s degree or equivalent required.
• Minimum of 5 years of related experience as Sr CRA.
• Strong analytical problem-solving and critical thinking.
• Working knowledge of FDA/EMA/PMDA and ICH GCP.

Responsibilities

• Perform site management and monitoring visits per protocol and ICH GCP.
• Coordinate with CTL and client functions to support site activation.
• Review study metrics and identify sites for oversight monitoring.
• Ensure timely regulatory filings and safety reporting.
• Write accurate monitoring visit and oversight reports.
• Maintain inspection readiness and data integrity.

Skills

Effective communication

Interpersonal skills

Written reports

Prioritization and time management

Analytical problem-solving

Cross-functional collaboration

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

EDC

CTMS

Data repositories

Job description

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management activities for sponsored studies in compliance with ICH GCP and local regulations. The role involves on-site and remote visits, collaboration with study teams and investigator sites, and oversight of data and operational metrics.

Responsibilities include conducting site qualification/initiation/interim/close-out visits, maintaining regulator files, and ensuring timely safety reporting.