Senior CRA, Early Development – Remote Site Oversight

Parexel; Frankfort (KY); Remote; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Sr. Clinical Research Associate to support monitoring and site management for sponsored studies. You will work with cross-functional teams, conduct site visits (onsite and remote), and ensure high-quality data and regulatory compliance across study activities.

Responsibilities include oversight of monitoring plans, data review, and collaboration with CTLs and CRO partners to ensure study deliverables meet timelines and quality standards.

Qualifications

• Bachelor's degree in life sciences or equivalent.
• Minimum 5 years of Sr CRA experience or similar role.
• Strong knowledge of ICH GCP guidelines and regulatory requirements (FDA/EMA).

Responsibilities

• Perform site management activities to ensure protocol compliance and monitoring plan adherence.
• Conduct site qualification, initiation, interim, and close-out visits (onsite or remote).
• Review site data and oversee CRO CRA performance and site issues.
• Prepare Oversight Monitoring Plans and monitoring reports with accurate documentation.

Skills

ICH GCP knowledge

Site management

Data review

Education

Bachelor's degree

Tools

CTMS

EDC

Microsoft Office

Job description

Parexel is seeking a Sr. Clinical Research Associate to support monitoring and site management for sponsored studies. You will work with cross-functional teams, conduct site visits (onsite and remote), and ensure high-quality data and regulatory compliance across study activities.

Responsibilities include oversight of monitoring plans, data review, and collaboration with CTLs and CRO partners to ensure study deliverables meet timelines and quality standards.