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Summary: Provides support to Study Manager and other study team members. Tracks and maintains study and investigator-related clinical trial documents, files, study supplies, and vendor information.  Keeps study related documentation current and filed.  This position is responsible for the appropriate collection, scan, index, quality check, file, archival and retrieval of records for the Clinical Operations’ section of the Trial Master Files (TMF) and electronic Trial Master Files (eTMF) for assigned studies.  May also be assigned other tasks to support study teams.

Responsibilities:

  • Set-up Clinical Operations’ paper or electronic folders, as applicable Process Clinical Operations’ administered TMF records: scan, index, quality check and file against pre-defined quality criteria and in compliance with service levels
  • Manage TMF inventory trackers or eTMF reports.
  • Support TMF/eTMF review process by working closely with study teams
  • Prepare for receipt of CRO’s portion of the TMF/eTMF Process the CRO’s portion of the TMF/eTMF in a timely and controlled manner in accordance with procedures
  • Assists study team in collection and tracking of essential documents, IRB submissions, procurement and shipment of supplies to sites.
  • Assists with review of both internal and external documents, including essential documents and IRB applications.
  • Maintains clinical trial master files (TMF and eTMF) and keeps all documentation current. Assists with inventory of the TMF/eTMF.
  • Provides meeting agendas, minutes and action items for study related meetings.
  • Coordinates study team activities on behalf of study management.
  • Performs other tasks as directed by line management or project leadership.

 

Requirements:

  • Competent computer skills including MS Office Suite.
  • Experience working with eTMF systems is preferred
  • Experience working in a regulated environment such as a CRO or pharmaceutical company is preferred.

Skills & Attributes:

  • Demonstrated good communication skills (written and verbal).
  • Attention to detail.
  • Able to work in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities.
  • Ability to work in a team environment as well as independently
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