Description
As a Clinical Research Associate at ICON Strategic Solutions in Denver, 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.
Key responsibilities include:
- Conducting site visits, including selection, initiation, routine monitoring, and close-out
- Ensuring site compliance with ICH-GCP, SOPs, and regulations
- Maintaining documentation in CTMS and eTMF systems
- Supporting site staff training and maintaining compliance records
- Monitoring patient safety and reporting adverse events
- Supporting subject recruitment and retention efforts
- Overseeing drug accountability and ensuring proper storage and return
- Resolving data queries and driving high-quality data entry
- Documenting site progress and escalating risks or issues
- Assisting with tracking site budgets and ensuring timely payments
- Collaborating 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, problem-solving, and teamwork skills
- Ability to travel up to 60-75% for on-site monitoring visits across the west region
ICON offers a competitive salary range of $91,336.00-$114,170.00 and a comprehensive benefits package, including health and wellbeing programs, retirement and pension plans, life assurance, and employee assistance programs.