Description
As a Clinical Research Associate 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, conducting site visits, ensuring compliance with regulations, and maintaining up-to-date documentation.
Responsibilities:
- Conduct 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 and report adverse events
- Support subject recruitment and retention efforts
- Oversee drug accountability and ensure proper storage and return
- Resolve data queries and drive timely data entry
- Document site progress and escalate risks to the clinical team
- Assist in tracking site budgets and ensuring timely site payments
- Collaborate with cross-functional partners
Requirements:
- Bachelor's degree in Life Sciences or equivalent, or a qualified RN
- 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experience monitoring across multiple therapeutic areas
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Clear communication and problem-solving skills
- Ability to travel up to 60-75% for on-site monitoring visits
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