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Clinical Study Associate

Delaware All, DE

Posted: 11/12/2018 Job Type: Clinical Job Number: JN -112018-23019
  • Clinical Study Associate
  • Primarily responsible for coordinating the various aspects of clinical trials during the start-up phase.
  • Works as part of a clinical delivery team providing support, guidance and advice on a local level.
  • Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery.
  • Strong VEEVA eTMF experience, ICF review, communication skills, organizational skills, excel/tracking.
    Responsibilities include:
    Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents.
    Assist in coordination and administration of clinical studies from start-up through site activation.
    Actively participate in local Study Delivery Team meetings and work cross functionally with Contracts, Feasibility and Study Support Services in US
    Activate study sites in compliance with Procedural Documents.
    Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
    Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.
    Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
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