Clinical Research Associate (Start-Up) - Oncology

As a Clinical Research Associate (Start-Up) - Oncology at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

You will be responsible for multiple trials within cross therapeutic areas, with a focus on start-up.

Key responsibilities include:

• Collaborating with country operations teams to identify, select, and activate clinical trial sites
• Performing Site Qualification Visits (SQVs) to assess site eligibility
• Building strong relationships with site personnel
• Ensuring adherence to ICH-GCP guidelines, local regulatory standards, and internal SOPs
• Coordinating with country operations teams to collect essential documents
• Acting as the main point of contact for sites, study teams, and external stakeholders
• Managing investigator contracts, regulatory documents, and site-specific start-up activities
• Providing regular status updates to internal and external stakeholders
• Monitoring, reporting on, and analyzing KPIs related to site selection and start-up timelines
• Proactively identifying and addressing issues that may delay study initiation or affect trial deliverables
• Maintaining precise documentation for inspections
• Supporting sites during the activation phase
• Facilitating coordination with site staff to ensure pre-study requirements are met
• Possibly assisting in audit and inspection preparations

Requirements include:

• Minimum B.S., R.N., or equivalent degree, preferably in Biological Sciences
• 2-3 years' experience in monitoring pharmaceutical industry clinical trials
• 1-3 years' experience monitoring oncology clinical trials
• Study start-up experience required
• Analytical/risk-based monitoring experience is an asset
• Ability to drive patient recruitment strategies
• Ability to partner closely with investigator and site staff
• Strong communication and influencing skills
• In-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements
• Legal authorization to work in the United States

ICON offers a competitive and comprehensive total rewards package, including:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities