ICON plc
ICON plc
ICON plc este o organizație globală de cercetare în regim contractual, care deservește industriile din domeniul sănătății și farmaceutic. Activitatea sa cuprinde servicii clinice, de consultanță și comerciale care sprijină dezvoltarea medicamentelor, de la cercetarea timpurie până la activitățile post-comercializare. Compania oferă soluții precum studii clinice descentralizate, evaluarea siguranței cardiace, laboratoare clinice pentru etapele timpurii, imagistică medicală, informații de reglementare și dovezi din lumea reală. ICON plc dispune, de asemenea, de expertiză terapeutică în domenii precum bolile cardiovasculare, oncologia, medicina internă, terapiile celulare și genice și medicamentele biosimilare, combinând analiza datelor cu o abordare axată pe pacienți pentru a contribui la avansarea programelor clinice.

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.

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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