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)
Collaborating with cross-functional partners including CTAs, LTMs, and CTMs
Requirements
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, including Neurology and Ophthalmology experience preferred.
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 southeast region, preference given to candidates residing in the Miami or Tampa area, to support efficient regional travel