Linical
Linical
Linical — дәрі-дәрмектерді әзірлеудің барлық кезеңінде биофармацевтикалық компанияларға қызмет көрсететін жаһандық клиникалық зерттеу ұйымы. Оның қызметі онкология, неврология, психиатрия, иммунология және эндокринологияны қоса алғанда, әртүрлі терапиялық бағыттар бойынша клиникалық әзірлеу стратегиясын, хаттама жасауды, реттеуші мәселелер жөніндегі кеңес беруді, пациенттерді тартуды және зерттеулерді басқаруды қамтиды. Linical халықаралық ауқымын жекелендірілген қолдаумен және деректерді сенімді жинауға бағытталған тәсілмен ұштастырып, клиенттеріне операциялық мәселелерді шешуге және бүкіл әлемдегі пациенттерге арналған жаңа емдеу әдістерін әзірлеуге бағытталған күрделі клиникалық зерттеулерді ілгерілетуге көмектеседі.

Clinical Trial Associate — United States (Remote)

Support Linical’s clinical research programs through trial documentation, TMF administration, regulatory submissions, site support, and coordination with study teams.

Сипаттама

  • Provide administrative support across the clinical project team
  • Support the Project Manager with communications involving study teams and sites
  • Assist with site identification and feasibility assessments
  • Gather initial essential documents from participating sites
  • Support study start-up, including regulatory documentation, essential documents, and IRB/IEC submissions
  • Prepare study-specific documents and materials
  • Keep study organizational charts and project trackers current
  • Conduct background checks for Principal Investigators
  • Set up Investigator Site Files and adapt study templates
  • Assign training documents in the Learning Management System and maintain the Project Team Training Matrix
  • Arrange and ship study materials and supplies to sites and Clinical Research Associates
  • Support Annual and Continuing Review IRB submissions in North America
  • Coordinate meetings and document minutes and follow-up actions
  • Arrange translations when needed
  • File, review, classify, name, and maintain documents in the electronic Trial Master File in line with the eTMF plan
  • Support scheduled TMF quality-control reconciliations and project close-out activities
  • Set up project email accounts and help organize email filing
  • Maintain strong working knowledge of Veeva Vault for eTMF administration and user support
  • Complete additional duties as assigned

Талаптар

  • Associate degree or comparable professional experience
  • At least two years of experience in clinical research
  • Strong written and verbal communication skills with proficient English
  • Excellent interpersonal and communication abilities
  • Familiarity with ICH, GCP, FDA, MHRA, EMA, and applicable local guidelines
  • Proven ability to work effectively within a matrixed team
  • Consistent focus on quality and meticulous attention to detail
  • Ability to prioritize work and manage multiple responsibilities
  • Working knowledge of computer systems, software applications, and operating systems
  • Ability to sit for extended periods while working at a computer

Артықшылықтар

  • Paid time off
  • Comprehensive benefits package

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