FSP - Clin Trials Admin I

Job Overview:

Clinical Trial Administrator

Office Based in Whippany, New Jersey

In this role, the selected candidate will document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support; assist in the preparation of study and site specific materials in accordance with relevant SOPs and computer complete minute taking and documentation for sponsor/external or internal teleconferences as requested.

Additional responsibilities include:
  • Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
  • Maintain the Project Directory
  • Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting
  • Provide support to project team (e.g. proof-reading and editing correspondence, mailings,
    shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.)
  • Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
    Audit and CAPA tracking
  • Set up and maintain clinical investigator files and documentation
  • Liaise with vendors, as needed, for study conduct such as printing study materials and/or
    external systems access for study team members.
  • Coordinate and plan study supply shipments with vendors
  • Maintain and confirm shipment information such as courier tracking numbers and
    date of shipping and delivery
  • Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other
    study-specific ancillary supplies (i.e. diary cards, patient visit reminders)
  • Generate reports as needed, for example CTMS site contact information list
  • Work with the In-House CRA and other project team members on reconciliation of data
    with CTMS.
  • General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
  • Perform other administrative duties as assigned by Line Manager, Project Managers or
    Clinical Trial Lead.


• Bachelor's degree


Minimum Required:
• Minimum one (I) year administrative experience or equivalent training
• Good oral and written communication skills
• Good organizational and time management skills
• Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)
• Aptitude for handling and proof-reading numerical data, some spreadsheet software
• Good typing skills
• Good spelling and proof-reading skills
• Ability to operate standard office equipment (e.g., fax, copier)
• Works efficiently and effectively in a matrix environment

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