Lead CRA

ICON plc

3d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are currently seeking a Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Lead 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.

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.

Nice To Haves

• Experience in Gene Therapy or Ophthalmology studies (complex indications)

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior