Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system- Ensures allocated tasks are performed on time, within budget and to a high-quality standard- Proactively communicates any risks to project leads- Supports 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- Provides system support (i.e. GoBalto & eTMF)- Supports RBM activities- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members- Supports scheduling of client and/or internal meetings- Reviews and tracks local regulatory documents- Transmits documents to client and centralized IRB/IEC- Analyzes and reconciles study metrics and findings reports- Assists with clarification and resolution of findings related to site documentation- Maintains vendor trackers- 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 requestOther responsibilities may include, but are not limited to:- Providing administrative support for site-initiated amendments and site supply shipments- Manage couriers- Supporting CRAs in visit preparation- Supporting CTMs/PMs in country project related expenditures- Assist in translation and translation QC- Distribute country and site level communications- Create and maintain investigator list- QC of country and site-level documents- Submission of complete country and site-level documents to eTMF and related tracking in CTMS- Performs document tracking in CTMS, verifies appropriate country or site level activity plans are applied, updates country level activities/documents for amendments- Compile and distribute Investigator Site File (ISF) and Pharmacy binder to site prior to SIV- Review eTMF reports and Preclarus dashboards to identify country and site level essential documents statuses- Follow up on outstanding/missing study documents to be sent to site.- Forward "wet ink" documents retrieved from sites- Periodic Safety Reporting for Urgent Safety Measures Notifications
