Senior CRA: Remote Site Monitoring & Oversight

Parexel; Helena (MT); On-site; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (Sr. CRA) to join our team in the United States. The Sr. CRA will oversee site management, monitoring and close-out of assigned trials, ensuring patient safety and quality study execution in line with GCP and client standards.

Key duties include managing site activation through database lock, acting as primary contact for sites, coordinating with SCP, and driving recruitment and QA through compliant processes. Extensive travel is required.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Monitoring experience: minimum 3 years in clinical research site monitoring (preferably Oncology).
• Significant travel (60-80%) within area; may require international travel and some weekend travel.

Responsibilities

• Maintain site management and monitoring across trials to ensure patient safety and data integrity.
• Coordinate with Site Care Partner (SCP) and study team for site setup, activation, monitoring and close-out.
• Ensure timely submission of reports and adherence to SMP, SOPs and regulatory requirements.
• Provide investigator site development, coaching and training to ensure ongoing protocol compliance and patient safety.

Skills

Clinical trial knowledge

GCP/ICH

Monitoring experience

FDA regulations

Oncology experience

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking a Senior Clinical Research Associate (Sr. CRA) to join our team in the United States. The Sr. CRA will oversee site management, monitoring and close-out of assigned trials, ensuring patient safety and quality study execution in line with GCP and client standards.

Key duties include managing site activation through database lock, acting as primary contact for sites, coordinating with SCP, and driving recruitment and QA through compliant processes. Extensive travel is required.