Senior Clinical Research & Operations Lead

GI Alliance; Lone Tree (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

GI Alliance is seeking a CRC/Operations Lead to run clinical trials end-to-end and to act as a trusted resource for operational questions, staff training, and workflow support across sites.

You will guide staff on study protocols, policies and documentation, oversee onboarding, troubleshoot daily challenges, and collaborate with investigators and market leadership to ensure compliant, timely enrollment and high-quality data.

Qualifications

• Experience in managing clinical trials and coordinating multiple studies.
• Strong knowledge of FDA, GCP, ICH, and regulatory requirements.
• Ability to train, mentor and onboard staff.

Responsibilities

• Manage assigned clinical trials end-to-end, including participant visits, data collection, source documentation, and sponsor relations.
• Lead multiple studies with varying indications while ensuring protocol compliance.
• Provide day-to-day operational support and interpret study protocols and SOPs for staff.
• Support training and onboarding, and assist with administrative oversight such as timecard reviews.
• Attend site SIVs and sponsor meetings to ensure smooth start-up and expedited enrollment.
• Assist with feasibility activities and site visits, contributing to business development.
• Train and mentor CRCs, ensure Investigator relations, and maintain ALCOA-C documentation standards.
• Maintain certifications and knowledge of FDA, GCP, ICH, and state regulations.

Job description

GI Alliance is seeking a CRC/Operations Lead to run clinical trials end-to-end and to act as a trusted resource for operational questions, staff training, and workflow support across sites.

You will guide staff on study protocols, policies and documentation, oversee onboarding, troubleshoot daily challenges, and collaborate with investigators and market leadership to ensure compliant, timely enrollment and high-quality data.