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

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 across multiple therapeutic areas
Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
Willing and able to travel up to 50% for on-site monitoring visits across the midwest region; preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel

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

Clinical Research Associate II

Key skills