Senior CRA: Site Leadership & Monitoring Expert

Parexel; Denver (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate to act as the primary site contact and site manager across all phases of a clinical study. The role requires monitoring sites to ensure data integrity and participant safety in compliance with ICH-GCP and sponsor SOPs.

The candidate will develop strong site relationships, manage regulatory documentation in CTMS/eTMF, and mentor junior CRAs. Travel domestically and internationally is expected, roughly 65–75% of the time.

Qualifications

• Minimum 4 years of direct site management (monitoring) experience.
• Bachelor’s degree preferred with emphasis in science/biology.
• Strong knowledge of GCP/ICH and regulatory requirements.
• Excellent English and local language communication.

Responsibilities

• Act as the primary site contact and site manager across all study phases.
• Monitor sites in compliance with ICH-GCP, Sponsor SOPs, and regulations.
• Manage site initiation, monitoring and close-out visits; ensure visit reports.
• Maintain regulatory and study master documentation (CTMS/eTMF).
• Mentor junior CRAs and support audits/inspections.

Skills

Site management

Monitoring

GCP/ICH knowledge

Mentoring

Data review/analysis

Comunication skills

Travel readiness

CTMS/eTMF

Education

Bachelor's degree in science/biology

Tools

CTMS

eTMF

MS Office

Job description

Parexel is seeking a Senior Clinical Research Associate to act as the primary site contact and site manager across all phases of a clinical study. The role requires monitoring sites to ensure data integrity and participant safety in compliance with ICH-GCP and sponsor SOPs.

The candidate will develop strong site relationships, manage regulatory documentation in CTMS/eTMF, and mentor junior CRAs. Travel domestically and internationally is expected, roughly 65–75% of the time.