.**Summarized Purpose**:Provides administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. Maintains procedures, guidelines and documentation. Ensures appropriate maintenance of project records and that all regulatory documents are correct, processed and approved. Completes data entry and maintenance of data base repositories. Assists in preparation or creation of reports and completes data collection for analysis. Completes quality review and demonstrates audit readiness.**Essential Functions and Other Job Information**- Completes review, coordination and compilation of files and other materials.Distributes project documents and supplies.- Processes and tracks local regulatory, study specific or department documents.- Performs file review. Organizes and maintains correspondence files and otherdepartmental records. Analyzes and reconciles project documents, metrics andfindings reports within specified timelines.- Provides clarification and resolution of findings related to documentation.- May assist with translation materials and translation QC upon request.- Composes, copies and distributes communications, reports, documents andforms. Performs mass mailings and communications.- Maintains vendor trackers.- Provides accesses to company, client and vendor systems.- Processes local payments (translations, EC/IEC, other local vendors, etc.)- Assists on project management ad-hoc activities, producing reports or on study plan edition.- Coordinates team conference calls and completes and distributes meetingminutes from internal/client/vendor meetings as applicable.- Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development toensure continued compliance.- Maintains a basic knowledge of project protocol and the ability to implementproject plans with specific guidelines and accountable for meeting applicableproject timelines in accordance with the contract.- Serves as a resource to the project team.- Assists in ensuring audit ready files. Contributes to company, client and federal regulatory requirements/audit responses as needed.- Acts as a mentor for research and project teams by demonstrating the role of an experienced senior project assistant in the preparation and execution of alladministrative functions.- Assists in training junior staff and supports departmental leadership indetermining training needs.**Education and Experience**:High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Technical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years)