Principal CRA
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to 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. 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.
What You Will Do
Your focus will be on coordinating clinical trial monitoring delivery, resolving issues, and developing team capability. Key responsibilities include:
- 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.
Your Profile
You will have solid clinical trial monitoring experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:
- 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.
- Experience in Oncology and Phase I
- 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.
- Willingness to travel as required (approximately 60%)
- Fluent German and English
What ICON can offer you
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
