Salary
💰 $110,520 - $138,150 per year
Tech Stack
Google Cloud Platform
About the role
- Serve as the primary point of contact between investigational sites and the sponsor
- Conduct 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 and ensure 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
- Travel up to 50% for on-site monitoring across the West region
Requirements
- 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
- Experience across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology
- 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 West region
- Preference for candidates residing near major HUB airports in the West Region to support efficient regional travel