What are the responsibilities and job description for the Lead Clinical Research Associate position at ICON Strategic Solutions?
Lead CRA - Ophthalmology or Gene Therapy
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
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.
What You Will Be Doing:
- 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:
- 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.
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.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.