Lead Clinical Research Associate - Home-Based

at  ICON

We are currently seeking a Lead Clinical Research Associate (Lead 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.

• 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.
• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field highly 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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We’re proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles

• 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.
• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field highly 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