Description
As a Clinical Research Associate - Oncology - US at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will implement and monitor clinical trials to ensure sponsor and investigator obligations are met and comply with local regulatory requirements and ICH Good Clinical Practice guidelines.
Key responsibilities include:
- Assessing the qualification of potential investigative sites and initiating clinical trials
- Conducting site startup activities, including regulatory documents collection and budget negotiations
- Reviewing and verifying accuracy of clinical trial data
- Providing regular site status information to team members and trial management
- Completing monitoring activity documents and escalating site and trial-related issues
- Performing essential document site file reconciliation and source document verification
- Assessing investigational product accountability and verifying serious adverse event reporting
Requirements:
- Undergraduate degree in a clinical, scientific, or health-related field
- 2-5 years of clinical monitoring experience (CRA 2) or 5+ years (Sr CRA)
- Oncology monitoring experience required
- Fluent English
- Knowledge of ICH and local regulatory authority regulations
- Experience with feasibility, site selection, and site startup
- Budget negotiations experience preferred
ICON offers a competitive and comprehensive total rewards package, including:
- Competitive base salary and performance-related incentives
- Health and wellbeing programs
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programs and wellbeing resources
- Learning and development opportunities