Description
As a Senior Clinical Research Associate - Oncology - West Region at ICON Strategic Solutions, you will serve as the primary point of contact between investigational sites and the sponsor.
You will conduct various site visits, including selection, initiation, routine monitoring, and close-out, to ensure site compliance with ICH-GCP, SOPs, and regulations.
Key responsibilities include:
- Serving as the primary point of contact between investigational sites and the sponsor
- Conducting site visits, including selection, initiation, routine monitoring, and close-out
- Ensuring site compliance with ICH-GCP, SOPs, and regulations
- Maintaining up-to-date documentation in CTMS and eTMF systems
- Supporting and tracking site staff training and maintaining compliance records
- Monitoring patient safety and ensuring timely and accurate AE/SAE/PQC reporting
- Supporting subject recruitment and retention efforts at the site level
- Overseeing drug accountability and ensuring proper storage, return, or destruction
- Resolving data queries and driving timely, high-quality data entry
- Documenting site progress and escalating risks or issues to the clinical team
- Assisting in tracking site budgets and ensuring timely site payments
- Collaborating with cross-functional partners, including CTAs, LTMs, and CTMs
To be considered for this role, you should:
- Have a Bachelor's degree in Life Sciences or equivalent, or be a qualified RN
- Be eligible to work in the United States without visa sponsorship
- Have 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Have experience monitoring Oncology and/or Hematology Oncology trials
- Be proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Be a clear communicator, problem-solver, and collaborative team player
- Be willing and able to travel up to 50% for on-site monitoring visits across the West region
ICON offers a competitive and comprehensive total rewards package, which may include:
- 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