• 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 other departmental records. Analyzes and reconciles project documents, metrics and findings 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 and forms. 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 meeting minutes 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 to ensure continued compliance.
• Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project 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 all administrative functions.
• Assists in training junior staff and supports departmental leadership in determining training needs