Blue Bell, CT30+ days ago
What You Will Be Doing: • 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. You Are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RNE 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 Experience monitoring Oncology studies 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 northeast region; preference given to candidates residing in Connecticut near major HUB airports to support efficient regional travel.