Clinical Research Associate II

🕒 June 26

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

🎯 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 monitoring Oncology (I.e. Prostate Cancer, and Lung Cancer) and/or Hematology Oncology clinical 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 southeast region; preference given to candidates residing in West Palm Beach, FL near major HUB airports to support efficient regional travel

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways

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