Principal CRA

About the Role

As a Principal CRA at ICON, you will oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. Your focus will be on coordinating clinical trial monitoring delivery, resolving issues, and developing team capability.

Key Responsibilities

• Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines
• Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance
• Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations
• Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies
• Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials

Qualifications

• 2+ years of Global SIT principal or lead CRA experience including MVR report review
• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes
• Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively
• Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways