Clinical Operations Assistant
Job ID R0000033677 Category Clinical TrialsAbout this Role
Tasks will include:
• Track, scan, code, input meta data, and/or apply naming convention and send/file documents to the relevant study Trial Master File (TMF) as per the Trial Master File Plan.
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Trial Master File plan
• Photocopy, print, distribute and retrieval of documents, as needed
• Support on creating and review of Note to Files (NTF)
• Maintain basic quality check procedures to ensure accurate maintenance of documents
• Review/update TMF country and site issues in 30 days
• Review/update EDL (Essential Documents List)
• Review/update TMF milestones
• Clear QC stops (if applicable)
• Missing Letter Support (e.g. FUP letter, confirmation letter, cover e-mails,
etc...)
• Follow up with sites regarding pending documents
• Transfer of documents to sponsor TMF systems (if applicable)
Vendor Management
Track and manage vendor communication related to site staff access to systems
(e.g. EDC, IVRS) during activation
• Follow up with sites
• Study specific completion training
• Organization and print of ISF (Investigator Site File)
Payment Support • Review if Site payments funds are completed as per site contracts and
follow up with responsible team accordingly
• Contact Site Contract Lead Team to clarify any site contract question
before proceeding with payments
• Mark fees as payable in CTMS, when applicable
• Contact responsible team to obtain Payment Breakdown, when
applicable
• Support obtaining/processing site invoices (when applicable) as per
contract timelines
• Follow up with local finance + IPO
• Inform site about planned payment date
• Ad-Hoc
• Support any ad-hoc payment (includes EC/IRB submission fee payment)
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