Remote Senior CRA Phase I Expert

Parexel; Topeka (KS); Remote; USD 90,000 - 140,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support site monitoring and site management for client-sponsored studies. The role includes on-site and remote activities, collaboration with CTLs, and oversight of CRO partner activities to ensure study deliverables.

You will ensure compliance with ICH GCP, regulatory requirements, and client SOPs. The SrCRA will manage drug accountability, data integrity, and site documentation while participating in process improvements and

Qualifications

• Minimum of 5 years of related experience for Snr CRA.
• Strong analytical problem-solving skills and critical thinking.
• Working knowledge of the clinical drug development process, ICH GCP and regulatory requirements.

Responsibilities

• Perform site management and monitoring to ensure protocol and regulatory compliance.
• Conduct site visits (qualification, initiation, interim, close-out) on-site and remotely.
• Review study metrics and oversee CRO CRA/site performance for oversight visits.
• Write monitoring visit reports and ensure timely study documentation.
• Identify deviations, escalate issues, and support inspection readiness.

Skills

Analytical thinking

Problem solving

Communication skills

Time management

Team collaboration

Education

Bachelor's degree

Tools

Microsoft Office

EDC

CTMS

Data repositories

Job description

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support site monitoring and site management for client-sponsored studies. The role includes on-site and remote activities, collaboration with CTLs, and oversight of CRO partner activities to ensure study deliverables.

You will ensure compliance with ICH GCP, regulatory requirements, and client SOPs. The SrCRA will manage drug accountability, data integrity, and site documentation while participating in process improvements and