As a Clinical Research Associate II, you will join the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
ICON Romania is currently seeking an experienced CRA II to join our FSP team. This is a sponsor-dedicated role.
You will be part of a global biopharmaceutical company that leads in cell and gene therapy (CGT) and specializes in cardiology, hematology, oncology, endocrinology, and more.
What you will be doing:
- Performing on-site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws \& Regulations, Protocol, Site Monitoring Plan, and related documents.
- Participating in and providing input on site selection and validation activities.
- Conducting remote and on-site monitoring and oversight activities.
- Carrying out site visits, including validation, initiation, monitoring, and close-out visits, and preparing accurate reports promptly.
- Communicating with Investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance.
- Identifying, assessing, and resolving site performance, quality, or compliance issues.
- Managing and maintaining documentation in CTMS, eTMF, and other systems as appropriate and within timelines.
- Sharing best practices and acting as a process SME, mentor, or buddy within the CRA team.
- Supporting or leading audit/inspection activities as needed.
- Performing co-monitoring visits where appropriate.
Requirements:
- University degree.
- 2-3 years of direct on-site monitoring experience in bio/pharma/CRO.
- Proven skills in site management, including site performance and patient recruitment management.
- Good IT skills.
- Ability to analyze data/metrics and act accordingly.
- Capability to manage complex issues in a solution-oriented manner.
What ICON can offer you:
Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:
- Various annual leave entitlements.
- A range of health insurance options for you and your family.
- Retirement planning options to maximize savings.
- Global Employee Assistance Programme, TELUS Health, providing 24/7 support from over 80,000 professionals.
- Life assurance.
- Flexible country-specific benefits like childcare vouchers, bike schemes, gym memberships, travel passes, health assessments, and more.
Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion \& belonging are fundamental. We are committed to an inclusive, accessible environment free from discrimination. If you need reasonable accommodation during the application process or to perform your role, please let us know through this form.
We encourage you to apply even if you do not meet all requirements; you might be exactly what we need.
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