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Clinical Research Associate II

ICON plc

Orlando, FL; Blue Bell, PAOnsitePosted 15 days ago
Full TimeEntry LevelClinical DevelopmentCRO
Original posting ↗

Summary

ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.

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 monitoring across multiple therapeutic areas
  • 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 60% - 75% for on-site monitoring visits across southeast region; preference given to candidates residing in Orlando, FL near major HUB airports to support efficient regional travel

Requirements

  • Bachelor's degree in Life Sciences or equivalent, or qualified RN
  • Eligible to work in United States without visa sponsorship
  • 2+ years of on-site monitoring experience in pharmaceutical or CRO industry
  • Experience monitoring across multiple therapeutic areas
  • Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
  • Clear communicator, problem-solver, and collaborative team player
  • Willing and able to travel up to 60% - 75% for on-site monitoring visits

Benefits

  • Competitive base salary
  • Performance incentives
  • Medical, Dental & Vision
  • Retirement plans
  • Pension plans
  • Life assurance
  • Disability coverage
  • Employee assistance programs
  • Wellbeing resources
  • Learning and development

Company overview

ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.

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