Role Description
We are currently seeking a Principal Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Principal 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.
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Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines.
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Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance.
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Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations.
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Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies.
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Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.
Qualifications
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Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.
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Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
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In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
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Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
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Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
Benefits
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Various annual leave entitlements.
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A range of health insurance offerings to suit you and your familyโs needs.
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Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
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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 familyโs well-being.
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Life assurance.
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Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.