Senior Clinical Research Associate – Oncology
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Job Description
Senior Clinical Research Associate monitoring oncology trials for ICON, a global clinical research organisation. Conducting site visits, ensuring compliance, and overseeing patient safety, data quality, and site performance.
Responsibilities:
- Serve as the primary point of contact between investigational sites and the sponsor
- Conduct site selection, initiation, routine monitoring, and close-out visits
- 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 ensure timely, accurate AE/SAE/PQC reporting
- Support subject recruitment and retention at the site level
- Oversee drug accountability and 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 timely site payments as applicable
- Collaborate with CTAs, LTMs, and CTMs
Requirements:
- Bachelor's degree in Life Sciences or equivalent, or qualified RN
- Eligible to work in the United States without visa sponsorship
- 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experience across multiple therapeutic areas, ideally including Oncology and Hematology
- Proficiency in ICH-GCP and local regulatory requirements
- Proficiency with clinical systems such as CTMS and eTMF
- Willing and able to travel up to 50% for on-site monitoring visits across the northeast region
- Preference for candidates residing in New Jersey or New York near major hub airports
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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