Senior CRA (Phase I) – Remote Site Oversight

Parexel; Carson City (NV); Remote; USD 95,000 - 130,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate to support monitoring and site management for client-sponsored studies. The role involves on-site and remote interactions, collaboration with cross-functional teams, and oversight of activities carried out at investigator sites through CRO partners.

Responsibilities include monitoring visits, data verification, regulatory submissions, and maintaining site regulatory files.

Qualifications

• Bachelor's degree or equivalent.
• Minimum of 5 years of related experience for Sr CRA.
• Working knowledge of ICH GCP guidelines and regulatory requirements (FDA/EMA).

Responsibilities

• Perform site management and monitoring activities to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits (on-site and remote).
• Review site data (ALCOA) and ensure accuracy of documentation and study conduct.
• Write monitoring visit reports and study correspondence in a timely manner.
• Collaborate with CTLs and other client functions to support site activation and deliverables.
• Maintain inspection readiness and ensure data integrity at sites.

Skills

Site management

Monitoring visits

ICH GCP

Regulatory knowledge

Communication

CTMS/EDC proficiency

Education

Bachelor's degree

Tools

CTMS

EDC

Microsoft Office

Job description

Parexel is seeking a Senior Clinical Research Associate to support monitoring and site management for client-sponsored studies. The role involves on-site and remote interactions, collaboration with cross-functional teams, and oversight of activities carried out at investigator sites through CRO partners.

Responsibilities include monitoring visits, data verification, regulatory submissions, and maintaining site regulatory files.