Clinical Research Associate II
About The Position
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. This role serves as the primary point of contact between investigational sites and the sponsor, conducting all types of site visits, including selection, initiation, routine monitoring, and close-out. The associate will ensure site compliance with ICH-GCP, SOPs, and regulations, maintain up-to-date documentation in CTMS and eTMF systems, and support site staff training. Responsibilities also include monitoring patient safety, supporting subject recruitment and retention, overseeing drug accountability, resolving data queries, and documenting site progress. The role involves collaboration with cross-functional partners and may include tracking site budgets and ensuring timely site payments.
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
- 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
- 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
Nice To Haves
- Preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel
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
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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
