ICON plc
ICON plc
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.

Clinical Research Associate II (Remote, Texas)

Monitor sponsor-dedicated clinical trial sites for ICON Strategic Solutions while supporting regulatory compliance, patient safety, data quality, and site performance. This role serves as a key link between study sponsors and investigational sites.

Description

  • Act as the main liaison between the sponsor and investigational sites
  • Perform site selection, initiation, routine monitoring, and close-out visits
  • Verify site adherence to ICH-GCP, standard operating procedures, and applicable regulations
  • Keep clinical documentation current in CTMS and eTMF platforms
  • Track site staff training and maintain compliance records
  • Monitor participant safety and support prompt AE, SAE, and PQC reporting
  • Contribute to participant recruitment and retention activities
  • Manage drug accountability, including appropriate storage, return, or destruction
  • Resolve data queries and promote accurate, timely data entry
  • Record site progress and escalate emerging risks or issues
  • Provide support for site budgets and payments when required
  • Work closely with CTAs, LTMs, and CTMs

Requirements

  • Bachelor’s degree in Life Sciences or an equivalent qualification, or eligibility as a qualified registered nurse
  • Authorization to work in the United States without visa sponsorship
  • At least two years of on-site monitoring experience in the pharmaceutical or CRO sector
  • Monitoring experience spanning multiple therapeutic areas
  • Working knowledge of ICH-GCP, local regulatory standards, and systems such as CTMS and eTMF
  • Availability and ability to travel 60%–75% for monitoring visits across the Southeast region
  • Strong communication, problem-solving, and collaboration skills

Benefits

  • Base salary with performance-related incentives
  • Medical, dental, and vision coverage through health and wellbeing programs where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programs and wellbeing resources
  • Structured training and career development opportunities

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