Project Support Coordinator

Work Schedule

Environmental Conditions

Job Description

• Coordinates oversees and completes functions on assigned trial activities detailed on the task matrix.
• Performs department Internal Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital.
• Ensures allocated tasks are performed on time within budget and to a high quality standard. Bring ups in cases of variances (overburn/underburn) for self and junior PSCs reviews and re-distributes the tasks based on junior PSCs free capacity
• Supports the maintenance and oversight of study specific documentation and global support with specific systems tools and trackers to: study team lists tracking of project specific training requirements system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system.
• Provides system (i.e. CTMS Oracle Activate & eTMF) support by managing the access requests supervising study level documents maintaining audit readiness and presenting the non-compliance to the study team and suggesting resolution.
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to CRGs/Client eTMF as required performing CRGs/Client eTMF reviews and coordinating and proposing 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 and follow up for closure of action items if required.
• Exports and reconciles study metrics reports and if required analyzes and identifies issues (if involved in a Lead role.
• Maintains and regularly checks for correctness of vendor trackers.
• Drives and coordinates the compilation of Investigator Site File (ISF) template pharmacy binder with instruction from the Clinical Team Manager.
• Attends Kick off and Project Launch meetings and takes notes when required supports initial study set-up.

Education and Experience:

High / Secondary school diploma/ equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to at least 0 to 4 years).