Note: The job is a remote job and is open to candidates in USA. ICON Strategic Solutions is a global healthcare intelligence and clinical research organization dedicated to advancing new medicines and treatments. They are seeking a Clinical Research Associate II to act as the primary contact between investigational sites and the sponsor, ensuring compliance and monitoring site activities throughout the study process.
Responsibilities
- Serve as the primary point of contact between investigational sites and the sponsor
- 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 (as applicable)
- Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
Skills
- A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
- Eligible to work in United States without visa sponsorship
- A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experienced monitoring Oncology (i.e. Prostate Cancer, and Lung Cancer) and/or Hematology oncology
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- A clear communicator, problem-solver, and collaborative team player
- Willing and able to travel up to 50% for on-site monitoring visits across the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- 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
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