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Job Description · 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.
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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 request Other 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 · Apply updated site level activity plans, including push down of study documents from country to site level · Periodic Safety Reporting for Urgent Safety Measures Notifications