Senior Clinical Trials & Operations Lead

GI Alliance; Sun City West (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

GI Alliance in Sun City West, AZ is seeking a CRC/Operations Lead to oversee clinical trials and provide site-wide operational support. The role emphasizes staff guidance on study protocols, training, onboarding, and day-to-day problem solving to ensure smooth trial conduct.

The position focuses 75% on coordinating trials and 25% on research operations leadership, with responsibilities spanning sponsor relations, training, and regulatory oversight.

Qualifications

• 5+ years as a Clinical Research Coordinator or equivalent.
• Experience supervising or leading teams.
• Proven knowledge of GCP, FDA regulations, and site-level operations.

Responsibilities

• Manage assigned clinical trials end-to-end, including visits, data collection, source docs, and sponsor relations.
• Lead multiple studies with varying indications while ensuring protocol compliance.
• Develop strategies to recruit and retain participants in long-term trials.
• Train and mentor CRCs; provide protocol-specific training and shadowing.
• Maintain regulatory knowledge (FDA, GCP, ICH) and ensure ALCOA-C documentation.
• Support feasibility activities with investigators and site managers.
• Oversee timecards, supplies, study visit scheduling, and vendor setup.
• Assist in site audits and monitoring visits to support compliance.

Skills

Leadership

Communication

Time management

Study protocols

Mentorship

Job description

GI Alliance in Sun City West, AZ is seeking a CRC/Operations Lead to oversee clinical trials and provide site-wide operational support. The role emphasizes staff guidance on study protocols, training, onboarding, and day-to-day problem solving to ensure smooth trial conduct.

The position focuses 75% on coordinating trials and 25% on research operations leadership, with responsibilities spanning sponsor relations, training, and regulatory oversight.