Lidiya Yurukova

• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with minimal guidance and support.
• Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.
• Complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
• Maintain the Project Directory.
• Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
• Provide support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax, and photocopy documents, assemble study documents, and arrange meetings, etc.).
• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable.
• Audit and CAPA tracking.
• Set up and maintain clinical investigator files and documentation.
• Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
• Coordinate and plan study supply shipments with vendors.
• Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery.
• Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders); 12) Generate reports as needed, for example the CTMS site contact information list.
• Work with the In-House CRAs and other project team members on reconciliation of data with the CTMS.
• General communications to sponsors, sites and internal team members via electronic mail or courier or telephone.
• Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
• Train and mentor less experienced Clinical Trial Administrators.
• May serve as the Lead CTA on projects where there is more than 1 CTA (provide guidance, facilitate teleconferences, task review, task delegation).
• Liaise with other departments to ensure project delivery.
• All other duties as needed or assigned.

• Facilitate the creation, revision or inactivation of all project training requirements in the LMS
• Provide regular updates to project leaders and project coordinators on the status of all project related training requirements
• Monitoring and tracking compliance of study teams to training requirements leveraging LMS reporting capabilities and excel
• Send notifications to team members that are delinquent in completing training requirements
• Escalation of repeated delinquent training requirements to project leads
• Assign & remove role-based curricula to staff members throughout the life of the study
• Ensure accuracy and quality of all assignments and curricula for which they are responsible
• Administer updates to assignments and curricula in the LMS
• Run ad hoc reports from the LMS as needed
• Perform regular reconciliations between LMS generated compliance reports and project team maintained directories
• Extract from the LMS and file training records of all team members in the Trial Master File at study close
• Ensure all training requirements are removed and inactivated at study close out
• Support Project Training Supervisors with ad hoc requests
• Assist the Learning Operations & Solutions Strategy function as required with ad hoc tasks
• Perform other administrative duties as assigned by management.

• Providing technical and administrative support to project team under direction Clinical Project and Trial Managers
• Coordinating project administration
• Overseeing and completing administrative functions on assigned clinical trials; maintaining clinical trials: ERP system
• Communicating data, information and ideas to all members of the project team
• Regular tasks include but not limited to: Acting as a TMF Manager by ensuring quality review of documents; review of Expected Lists and Document placeholders
• Reporting of quality gaps and deliverable risks to the Team Management
• Ensuring deliverables comply with HA guidelines, Good Clinical Practices, and internal SOPs
• Generates quality reports and deliver to Management Team
• Performs department, Internal, Country file reviews as assigned and documents findings in appropriate system
• Investigator File Reviews (blinded) of English-speaking sites
• Investigator File Reviews (unblinded) of English-speaking sites
• Quality review of Site documents and document Identified Findings in CTMS
• Analyzing and reconciles study metrics and findings reports
• Assists with clarification and resolution of findings related to site documentation
• Working in conjunction with Project Manager to develop training matrix and monitor study team cross-functional departmental compliance
• Training codes creation, training compliance reports management within the Learning Management System
• Providing general administrative support for project team members, and ensuring that project related administrative tasks are carried out in a timely manner
• Maintaining study status tracking forms, trial supplies dispatch and receipt records, investigator payment records, etc
• Maintaining tracking databases – CTMS, Client and PPD Veeva Vault systems
• Supporting the maintenance of study specific documentation and global support with specific, tools and trackers including but not limited to: study team lists, system access management for organization/vendor/client and tracking of project level activity plans in appropriate system
• Supporting schedule and organization of client and/or internal meetings with completion of related meeting minutes
• Ad-hoc tasks associated with clinical trials and office administration as required.

• Providing technical and administrative support to project team under direction Clinical Project and Trial Managers
• Coordinating project administration
• Overseeing and completing administrative functions on assigned clinical trials; maintaining clinical trials: ERP system
• Communicating data, information and ideas to all members of the project team
• Regular tasks include but not limited to: Acting as a TMF Manager by ensuring quality review of documents; review of Expected Lists and Document placeholders
• Reporting of quality gaps and deliverable risks to the Team Management
• Ensuring deliverables comply with HA guidelines, Good Clinical Practices, and internal SOPs
• Generates quality reports and deliver to Management Team
• Performs department, Internal, Country file reviews as assigned and documents findings in appropriate system
• Investigator File Reviews (blinded) of English-speaking sites
• Investigator File Reviews (unblinded) of English-speaking sites
• Quality review of Site documents and document Identified Findings in CTMS
• Analyzing and reconciles study metrics and findings reports
• Assists with clarification and resolution of findings related to site documentation
• Working in conjunction with Project Manager to develop training matrix and monitor study team cross-functional departmental compliance
• Training codes creation, training compliance reports management within the Learning Management System
• Providing general administrative support for project team members, and ensuring that project related administrative tasks are carried out in a timely manner
• Maintaining study status tracking forms, trial supplies dispatch and receipt records, investigator payment records, etc
• Maintaining tracking databases – CTMS, Client and PPD Veeva Vault systems
• Supporting the maintenance of study specific documentation and global support with specific, tools and trackers including but not limited to: study team lists, system access management for organization/vendor/client and tracking of project level activity plans in appropriate system
• Supporting schedule and organization of client and/or internal meetings with completion of related meeting minutes
• Ad-hoc tasks associated with clinical trials and office administration as required.

• Providing technical and administrative support to project team under direction Clinical Project and Trial Managers
• Coordinating project administration
• Overseeing and completing administrative functions on assigned clinical trials; maintaining clinical trials: ERP system
• Communicating data, information and ideas to all members of the project team
• Regular tasks include but not limited to: Acting as a TMF Manager by ensuring quality review of documents; review of Expected Lists and Document placeholders
• Reporting of quality gaps and deliverable risks to the Team Management
• Ensuring deliverables comply with HA guidelines, Good Clinical Practices, and internal SOPs
• Generates quality reports and deliver to Management Team
• Performs department, Internal, Country file reviews as assigned and documents findings in appropriate system
• Investigator File Reviews (blinded) of English-speaking sites
• Investigator File Reviews (unblinded) of English-speaking sites
• Quality review of Site documents and document Identified Findings in CTMS
• Analyzing and reconciles study metrics and findings reports
• Assists with clarification and resolution of findings related to site documentation
• Working in conjunction with Project Manager to develop training matrix and monitor study team cross-functional departmental compliance
• Training codes creation, training compliance reports management within the Learning Management System
• Providing general administrative support for project team members, and ensuring that project related administrative tasks are carried out in a timely manner
• Maintaining study status tracking forms, trial supplies dispatch and receipt records, investigator payment records, etc
• Maintaining tracking databases – CTMS, Client and PPD Veeva Vault systems
• Supporting the maintenance of study specific documentation and global support with specific, tools and trackers including but not limited to: study team lists, system access management for organization/vendor/client and tracking of project level activity plans in appropriate system
• Supporting schedule and organization of client and/or internal meetings with completion of related meeting minutes
• Ad-hoc tasks associated with clinical trials and office administration as required.

• Performed all duties of a Senior Recruitment Consultant as listed in job title below
• Used sales, business development, marketing techniques and networking in order to attract business from client companies
• Visited clients to build and develop business relationships
• Developed a good understanding of client companies, their industry, what they do and their work culture and environment
• Advertised vacancies by drafting and placing adverts in a wide range of media
• Used social media to advertise positions, attract candidates and build relationships with candidates and employers
• Used candidate databases to match the right person to the client's vacancy
• Received and reviewed applications, managed interviews and tests and created a shortlist of candidates for the client.

• General admin tasks in Managed Care Services and Zip Integrated products Departments.