Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.e. GoBalto & eTMF)
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• 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