Job Description

• 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. Escalates in cases of variances (overburn/underburn).
• 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 (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents and maintaining audit readiness.
• Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG\'\'s/Client eTMF as required, performing CRG\'\'s/Client eTMF reviews and coordinating for issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes.
• Exports and prepare study metrics reports.
• Maintain vendor trackers.
• Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager.
• When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.