Position: Clinical Research Associate II (CRA II)
Location: Romania (Homeworking with occasional office visits in Bucharest)
Salary: Competitive
Start Date: 22nd February 2025
Closing Date: 24th March 2025
Company Overview:
ICON is one of the largest and most comprehensive clinical research organizations globally. As part of their FSP team, you will work with a global biopharmaceutical company specializing in Oncology, Vaccines, Infectious Diseases, Neuroscience, and Cardiovascular.
Role Overview:
As a Clinical Research Associate II, your primary responsibilities will include:
Site Management: Develop strong relationships with clinical sites, ensuring site activities are compliant with ICH-GCP, Sponsor SOPs, and local regulations.
Monitoring: Perform both remote and on-site monitoring, including validation, initiation, monitoring, and close-out visits. Document all visit activities promptly.
Documentation & Compliance: Collect and review regulatory documentation throughout the trial’s lifecycle.
Communication: Collaborate with investigators, site staff, and various departments (country operations, regulatory affairs, etc.) to resolve performance or compliance issues.
Site Performance: Identify and address site-related issues, including recruitment, protocol deviations, and site audits.
Training & Mentorship: Contribute to the CRA team's knowledge by acting as a Subject Matter Expert (SME), mentoring junior CRAs, and leading by example.
Requirements:
Education: B.A./B.S. in Science/Biology preferred.
Experience: 2+ years of site monitoring experience in a bio/pharma/CRO environment. Experience with oncology trials is advantageous.
Skills: Strong knowledge of Good Documentation Practices, site management, and data analysis. Ability to manage complex issues and implement solutions.
IT Proficiency: Experience with CTMS and other clinical systems.
What ICON Offers
ICON prioritizes employee well-being and work-life balance. They offer:
Competitive salary and benefits packages, including health insurance and retirement planning.
Global Employee Assistance Program (TELUS Health) offering 24-hour access to a network of specialized professionals.
Flexible benefits: Childcare vouchers, gym discounts, and more.
Company Culture:
ICON values diversity, inclusion, and belonging within the workplace. They focus on creating a diverse culture that fosters innovation, ensuring equal opportunities for all employees regardless of race, gender, sexual orientation, or disability.
Application Information:
Job Posting Date: 22nd February 2025
Closing Date: 24th March 2025
Location: Romania (Homeworking, occasional office visits in Bucharest)
To apply, visit ICON Careers.
ICON
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