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Clinical Trial Assistant - United States  

Company managed [?] Still accepting applications
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Posted on : 20 June 2017

Project Description


Responsibilities include, but are not limited to:
  • Assist in the preparation Of project and study-related documents including:  Investigator’s Brochures, Protocols, Informed Consent Forms, Monitoring Plans, and Study Manuals, as required. 
  • Assist with coordination of Case Report Forms (CRF) and CRF Guidelines, including participating in The Electronic Data Capture (EDC) user acceptance testing.  
  • Assist in the review of clinical data in EDC and data listings/reports.  
  • Assist in the coordination of the preparation of clinical contracts and site budgets. 
  • Assist in monitoring and tracking clinical trial progress and providing status update reports, study metrics, and regulatory documents. 
  • Assist in vendor support activities. 
  • Assist in the planning of investigator meetings and presentations, as required. 
  • Prepare meeting agendas and minutes. 
  • Facilitate mass study communications.      
  • Support department training needs and documentation.  Create      training, review, and approval workflows for new and/or updated SOPs.  Track training through the Training Matrix. 
  • Maintain www.clinicialtrials.gov website for all studies. 
  • Support department with shipments of study documents, supplies, and mass communications to sites as needed. 
  • Support Clinical Operations Department for administrative tasks and projects. 


EDUCATION/EXPERIENCE:
BA/BS/MS in health-related field or scientific discipline or equivalent combination of education and related-work experience.