Lead CRA

About the role

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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.

Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a 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.

Qualifications

• Advanced degree preferred.
• Experience in Gene Therapy or Ophthalmology studies (will consider other complex indications).

Skills

• Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.