Clinical Operations Hub Study Start-Up Specialist
Roche
Doha, Qatar
منذ 1 يوم
source : drjobs.ae
  • Updates knowledge on relatedregulatory requirements, ensures adherence and compliance withlocal regulations and internal procedures.
  • Executes all start-up activities prior to site activationon assigned studies, according to Rochestandards and aligned with study / project requirements andtimelines.
  • Prepares country and / or siteInformed Consent Form (ICF) and clinical study documents which needtranslation from English into local language.
  • Obtains ethics committees' and local regulatoryauthorities' approval. Prepares ongoing submissions,amendments and periodic notifications required by ethics committeesand regulatory authorities as needed within the country.
  • Update the relevant systems as required for tracking of the localIRBs / IECs and regulatory authorities activities .

  • Maintains and analyzes study start-up data (metrics) onassigned studies, ensuring optimal efficiency to reducestart-up timelines and identify opportunities for continuousimprovement.
  • Partners with Clinical StudyManagers (CSMs) and Clinical Study Specialists (CSSs) toprovide guidance on regulatory / ethics requirements, totrack and drive site activations and trial amendments submissions,by regularly reviewing and monitoring status ofsubmissions / activations.
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