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Linical
Linical
501 – 1.000 Angajați
Asistență medicalăConsultanțăLogistică
Linical este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul întregului proces de dezvoltare a medicamentelor. Activitatea sa acoperă strategia de dezvoltare clinică, proiectarea protocoalelor, consultanța de reglementare, recrutarea pacienților și gestionarea studiilor clinice în domenii terapeutice precum oncologia, neurologia, psihiatria, imunologia și endocrinologia. Combinând prezența internațională cu sprijinul adaptat nevoilor clienților și cu accentul pe colectarea fiabilă a datelor, Linical își ajută clienții să abordeze provocările operaționale și să avanseze studiile clinice complexe către noi tratamente pentru pacienți din întreaga lume.
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Locurile de muncă ale companiei

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.

USStatele Unite ale Americii
50.000 $ – 70.000 $ / an
RemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăAsociat pentru studii cliniceGeneral
Google Cloud PlatformVault

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • Paid time off
  • Comprehensive benefits package

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