Clinical Research Associate - Solid Organ Transplant Monitoring

Position Overview

We are seeking an experienced Clinical Research Associate (CRA) for a contract position supporting a transplant-focused clinical study in the Mid-West region of the United States. This role requires comprehensive oversight of clinical trial sites, predominantly across the West Coast, to ensure compliance and data integrity throughout the study duration.

Key Responsibilities

• Perform site initiation, routine monitoring, and close-out visits in adherence to the defined study schedule, averaging visits every six weeks with potential variation by site.
• Ensure clinical trial sites operate following the approved protocol, Good Clinical Practice (GCP), and all relevant regulatory standards.
• Collaborate closely with site personnel to facilitate patient enrollment, verify data precision, and enhance site effectiveness.
• Maintain thorough, accurate, and timely documentation including monitoring reports and study records.

Mandatory Qualifications & Skills

• Possess a bachelor's degree in scientific or health-related disciplines.
• Minimum of five years' experience functioning as a Clinical Research Associate.
• Demonstrated expertise in monitoring clinical trials involving solid organ transplants.
• Deep familiarity with GCP and International Council for Harmonisation (ICH) guidelines.
• Excellent communicator with strong organizational and analytical problem-solving abilities.
• Flexibility and willingness to travel extensively to various U.S. clinical sites, including Washington, California, Colorado, and others.

Additional Information

This is a full-time equivalent position starting as soon as possible on a six-month contract basis with potential for renewal.