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Document Specialist

Under limited supervision, assists with the maintenance and filing of records (documents, binders, electronic media, etc.) from Development Sciences 

 

  • Verifies document receipt
  • Reviews files at a high level for identification and consistency, (i.e.; number of pages and transmittal form accuracy)
  • Files, sorts, separates, photocopies, prints, scans, indexes, distributes labels and files a variety of clinical study records and documents.
  • May enter new and updated records information accurately in a variety of records management databases, such as the Vault eTMF, Clinical Document Management Database, Access and LiveLink (via scan / index software).
  • Performs searches and produces routine reports (e.g.  Study Site Listing from database, BI reports from Livelink, etc.).
  • Prepares inventory, shipment and retrievals of records to/from offsite storage.
  • Works with third party offsite storage facilities, in accordance with the DevSci Records Management (DSRM) SOP.
  • Acquires a basic understanding of Records Management database programs (i.e.; Access databases or other) and assists in the support of these database programs.
  • Fulfills requests for retrieval, reproduction, and re-filing of records or their electronic images (e.g. pdf) and other related records management requests.                                                                                                             
  • Communicates resource needs to manager to ensure DevSci Records Management is appropriately staffed and equipped for customer support as filing needs fluctuate.
  • Works according to and assists others in following DSRM department priorities.
    • 1-2 years applicable experience, including a minimum of 1-year relevant Records Management experience, with some knowledge of ICH/GCP, preferred.
    • Competent in the skills for the Records Management Assistant and the following:
      • Experience working with regulated files or in a records management environment is preferred
      • Strong organizational skills
      • Ability to identify and respond to problems
      • Strong time management skills
      • Able to identify Records Management related issues and take appropriate action
      • Basic understanding of records management requirements in Drug Development
      • Strong communication skills
      • Ability to work well with others (strong interpersonal skills)
    • Has an understanding of the clinical study phases involved in Drug Development and the corresponding records requirements.

 

  • AA preferred.
  • Combination of education and work experience providing competencies to perform the required responsibilities specific to position.
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