ICON plc
ICON plc
ICON plc — денсаулық сақтау және фармацевтика салаларына қызмет көрсететін жаһандық келісімшарттық зерттеу ұйымы. Компанияның жұмысы бастапқы зерттеулерден бастап нарыққа шығарудан кейінгі қызметтерге дейін дәрі-дәрмек әзірлеуді қолдайтын клиникалық, консультациялық және коммерциялық қызметтерді қамтиды. ICON plc орталықтандырылмаған клиникалық зерттеулер, жүрек қауіпсіздігі, ерте клиникалық зертханалар, медициналық бейнелеу, реттеуші ақпарат және нақты өмір деректері сияқты шешімдер ұсынады. Сондай-ақ компания жүрек-қантамыр аурулары, онкология, ішкі аурулар, жасушалық және гендік терапиялар, биосимилярлар сияқты бағыттарда терапиялық тәжірибесін қолданып, клиникалық бағдарламалардың ілгерілеуіне көмектесу үшін деректерді талдауды пациентке бағдарланған тәсілдермен ұштастырады.

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.

Сипаттама

  • 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

Талаптар

  • 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

Артықшылықтар

  • 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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