Phase I Senior CRA: Remote Monitoring & Oversight

Parexel; Boise (ID); Remote; USD 100,000 - 130,000; Full time

Job summary

Parexel is seeking a SrCRA to support site management and monitoring activities for sponsored studies. The role collaborates with clinical study teams to ensure deliverables meet ICH GCP and regulatory standards.

The SrCRA will conduct on-site and remote visits, review data, and maintain relationships with investigator site staff while ensuring successful study conduct and issue resolution across multiple sites.

Qualifications

• Bachelor's degree in a relevant field.
• Minimum of 5 years of related Sr CRA experience.
• Working knowledge of ICH GCP and applicable regulatory requirements (FDA, EMA, PMDA).
• Familiarity with CTMS, EDC and data repositories.

Responsibilities

• Perform site management and monitoring activities in line with protocol, monitoring plan, ICH GCP, local regulatory requirements and client SOPs.
• Review site performance and oversee trials through CRO partnerships and investigator site personnel.
• Prepare monitoring visit reports, oversight visit reports and study correspondence in a timely manner.
• Identify protocol deviations, escalate non-compliance, and resolve study-related issues with cross-functional teams.
• Maintain ongoing communication with site staff and study teams to ensure study deliverables.

Skills

Analytical problem solving

Effective communication

Written reports

Time management

Education

Bachelor's degree or equivalent

Tools

CTMS

EDC

Microsoft Office

Job description

Parexel is seeking a SrCRA to support site management and monitoring activities for sponsored studies. The role collaborates with clinical study teams to ensure deliverables meet ICH GCP and regulatory standards.

The SrCRA will conduct on-site and remote visits, review data, and maintain relationships with investigator site staff while ensuring successful study conduct and issue resolution across multiple sites.