Description
As a Clinical Research Associate - Oncology at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will serve as the primary point of contact between investigational sites and the sponsor - Oncology, conducting site visits, ensuring site compliance, and maintaining up-to-date documentation.
Responsibilities:
- Serve as primary point of contact between investigational sites and the sponsor - Oncology
- Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
- Ensure site compliance with ICH-GCP, SOPs, and regulations
- Maintain up-to-date documentation in CTMS and eTMF systems
- Support and track site staff training and maintain compliance records
- Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
- Support subject recruitment and retention efforts at the site level
- Oversee drug accountability and ensure proper storage, return, or destruction
- Resolve data queries and drive timely, high-quality data entry
- Document site progress and escalate risks or issues to the clinical team
- Assist in tracking site budgets and ensuring timely site payments
- Collaborate with cross-functional partners
Requirements:
- Graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
- Eligible to work in United States without visa sponsorship
- Clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experienced monitoring oncology clinical trials
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Clear communicator, problem-solver, and collaborative team player
- Willing and able to travel up to 50% for on-site monitoring visits across Midwest region
Rewards & Benefits:
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes, including medical, dental, and vision coverage
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways