Project Support Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Completes a wide variety of technical, logistical, facilitative and central processes that are critical to study success; Provides project administrative support, including planning, organizing and coordinating responsibilities for Project Leads, Clinical Team Managers and other functional leads on designated projects throughout a study; Maintains procedures, guidelines and documentation, including project records; Completes data entry and supports maintenance of database repositories; Assists in preparing reports and data collection for analysis; Supports quality reviews. 

ial 
Functions 
 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, 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 prepares study metrics reports. 
 Maintains 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.