Bachelor’s degree in Life Sciences or equivalent, or qualified RN
2+ years of on-site monitoring experience in the pharmaceutical or CRO industry; Oncology/Hematology experience required
Proficient in ICH-GCP, local regulatory requirements, and clinical systems (CTMS and eTMF)
Willing and able to travel up to 50% for on-site monitoring; preference for candidates residing in New York City or near major hub airports
Requirements:
Serve as the primary point of contact between investigational sites and sponsor; conduct site visits (selection, initiation, routine monitoring, and close-out) and ensure site compliance with ICH-GCP, SOPs, and regulations
Maintain up-to-date documentation in CTMS and eTMF; support site staff training and maintain compliance records; monitor patient safety with timely 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 to 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; collaborate with cross-functional partners including CTAs, LTMs, and CTMs
Job description
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 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 Oncology Hematology area required
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 southeast region; preference given to candidates residing in New York City, near major HUB airports to support efficient regional travel
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