Clinical Operations

  • location: Lexington, MA
  • type: Contract
  • salary: $18.79 - $22.10 per hour

job description

Clinical Operations

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Clinical Document Management Specialist I

Job Summary

(Six month contract position) individual to capture, and protect the client's Research and Nonclinical (GLP) documentation. Support the Archives Customer Service Team transfer of records into OpenLab and the transfer for SharePoint 2010 to SharePoint Office 365

Job Responsibilities

Working member of an audit inspection-ready R&D paper and electronic Archives, responsibilities include following established procedures to:

80% of Responsibilities

  • Ensure the timely return/closure of records from authors
  • Manage the recall of archived records for legal and regulatory support
  • Support the integration of records acquired via mergers and acquisitions
  • Monitor team inbox regularly for questions and requests on records
  • Help to transition the use of Service Now, OpenLabs and SharePoint request management which includes, but is not limited to:

    • Support Training for new systems use and create quick use guides
    • Trouble shooting request in for users in new system
  • Support document Issuance: Issuing records to users in a timely manner including Reports, Protocols, Paper Notebooks, Databooks, Binders, etc.
20% of Responsibilities

  • Revising, writing, reviewing and initiating new SOPs as needed
  • Maintain contracts and relationships with vendors and third parties
  • Route POs, invoices, and vendor information in SAP, as well as recommend cost-effective improvement strategies
  • Conduct quarterly electronic laboratory and paper notebook training
Education & Qualifications

  • BS or BA required (or higher)
  • Experience as an archivist or documentation specialist, preferably in a biotech, pharmaceutical, or healthcare environment, with 1 years of experience BS or a BA, or pursuing of experience with MS or MA
  • Must be able to lift 15-30lbs on a routine basis.
  • Must also be able to use a stepladder to access physical records.
  • Experience working at a CRO, or in a Lab Science is a plus
  • CRM certification or MSLS/MSLIS is desirable
  • Experience with SharePoint, and Inventory/Content management systems such as (OmniRIM, FileBridge,etc.) preferred
  • Hands-on experience with multiple IT solutions commonly used in the industry for data capture and utilization:
  • In-depth knowledge of Microsoft Office products suite
  • Experience interfacing with customers or role in customer support
  • A collaborative and enterprising spirit
  • Recent experience with SharePoint (2010, and 365)
  • Superior judgment, decision making and problem solving skills with the ability to assess issues and determine the best course of action.
  • Skilled and experienced at managing vendors and third parties
  • Outstanding communication, presentation, and organization skills
  • Consultative and collaborative style with an ability to work well with others

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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