Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
According to the specific role (Central or Local), coordinates, oversees and
completes functions on assigned trials activities detailed on the task matrix.
• 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
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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 request.