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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