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Linical
Linical
501 – 1,000 कर्मचारी
परामर्शलॉजिस्टिक्सस्वास्थ्य सेवा
Linical एक वैश्विक क्लिनिकल अनुसंधान संगठन है, जो दवा विकास की पूरी प्रक्रिया में जैव-औषधि कंपनियों को सेवाएँ प्रदान करता है। इसका कार्य ऑन्कोलॉजी, न्यूरोलॉजी, मनोचिकित्सा, इम्यूनोलॉजी और एंडोक्रिनोलॉजी सहित विभिन्न उपचार क्षेत्रों में क्लिनिकल विकास रणनीति, प्रोटोकॉल डिज़ाइन, नियामक परामर्श, रोगी भर्ती और परीक्षण प्रबंधन तक फैला हुआ है। अंतरराष्ट्रीय पहुँच को अनुकूलित सहायता और विश्वसनीय डेटा संकलन पर केंद्रित दृष्टिकोण के साथ जोड़कर, Linical ग्राहकों को परिचालन संबंधी चुनौतियों से निपटने और दुनिया भर के रोगियों के लिए नए उपचारों की दिशा में जटिल क्लिनिकल अध्ययनों को आगे बढ़ाने में मदद करता है।
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कंपनी की नौकरियाँ

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.

USसंयुक्त राज्य
$50,000 – $70,000 / वर्ष
रिमोटपूर्णकालिकजूनियरमध्य स्तरआवश्यक भाषा: अंग्रेज़ीनैदानिक परीक्षण सहयोगीसामान्य
Google Cloud PlatformVault

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • Paid time off
  • Comprehensive benefits package

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