Work Schedule

Environmental Conditions

Job Description

Join Us as a Project Support Coordinator – Make an Impact at the Forefront of Innovation
As part of our global team, you’ll have the opportunity to independently provide administrative and technical support to project teams, including planning, organizing, and coordinating responsibilities at a global level.
• 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. Follows up for resolution of findings and escalates whenever necessary.
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
• Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers including, but not limited 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, tracking study level documents, maintaining audit readiness, communicating 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 CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews, 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.
• 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.

Qualifications:
Education and Experience Requirements:

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

Bachelor's degree preferred.  

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).  

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.