timely processing of documents sent to Client (e)TMF as assigned, performing
(e)TMF reviews, distributing mass mailings and communications as needed,
providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with
clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File
(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and
current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (Asia Pac only).
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
May provide system support (i.e., Activate & eTMF). May support RBM activities.
May support the maintenance of study specific documentation and systems,
including, but not limited to, study team lists, tracking of project specific training
requirements, system access management and tracking of project level activity
plans in appropriate system(s).
Transmits documents to client and centralized IRB/IEC.
Maintains vendor trackers.
Supports start-up team in Regulatory submissions.
Works directly with sites to obtain documents related to site selection.