Clin Ops Delivery Associate I

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 
plans in appropriate system.
• Provides system support ( 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.