About the role
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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Aplyr's read
ICON plc is a leading global provider of outsourced services in the pharmaceutical industry, attracting professionals in clinical research and data management.
What's promising
- •ICON plc has a strong global presence, enhancing its ability to manage international clinical trials effectively.
- •The company offers diverse career opportunities across various roles in clinical research and data analysis.
- •ICON's focus on innovation in pharmaceutical services supports its competitive edge in the industry.
What to watch
- •The pharmaceutical industry is highly regulated, which may limit flexibility in project execution.
- •ICON's reliance on large pharmaceutical clients could pose risks if partnerships dissolve.
- •The competitive nature of the CRO market may pressure ICON to maintain cost efficiency.
Why ICON plc
- •ICON plc specializes in comprehensive outsourcing solutions, differentiating it from competitors with narrower service scopes.
- •The company's integration of technology in clinical trials offers a unique advantage in data management.
- •ICON's strategic acquisitions have expanded its capabilities and market reach significantly.
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About ICON plc
ICON plc is a global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries.