demonstrates audit readiness.

Responsibilities include:
• Project administration
• Management of meetings & teleconferences
• Project support
• Document management
• Filing - PPD files
• Supplies & systems
• Central file reviews
• CTMS - Document/Activity tracking

Other responsibilities include, but are not limited to:
• Completes review, coordination and compilation of files and other materials
• Distributes project documents and supplies
• Processes and tracks study specific or department documents
• Performs Central file reviews as assigned and documents findings in appropriate system
• 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
• Assists with translation materials and translation QC upon request
• Attends Project Launch and Kickoff meetings and takes meeting minutes
• 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
• Assists with project management ad-hoc activities, producing reports or study plan editing
• 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 by demonstrating the role of an experienced PSC in the preparation and
execution of all administrative functions
• Assists in training junior staff and supports departmental leadership in determining training needs.

Qualifications:

Education and Experience:

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.