Lead CRA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

About the role

As a Lead Clinical Research Associate (CRA) at ICON, you will play a pivotal role in overseeing and managing clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. You will be a key contributor to the success of clinical trials by driving site performance, providing mentorship to CRAs, and ensuring the highest levels of data quality and patient safety.

Responsibilities

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

Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.
• 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.
• Experience in Gene Therapy or Ophthalmology studies (complex indications).

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who support well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.