İpek Miray Tukuş

-Supporting CRAs and the RSU team in accurately updating and maintaining clinical documents and systems (e.g., eTMF) to monitor site compliance and performance within project timelines. -Assisting the clinical team in the preparation, processing, distribution, filing, and archiving of clinical documents and reports in accordance with study scope and standard operating procedures. -Conducting periodic reviews and checks of study files. -Supporting CRAs and RSUs in the preparation, processing, distribution of clinical trial materials, and maintenance of monitoring information. -Assisting with the tracking and management of clinical data flow through CRFs. -Acting as a point of contact for the site.

Ensuring that the documents generated during the clinical trial are uploaded accurately and promptly into the eTMF system. Verifying that documents are placed in the appropriate categories and undergo necessary quality checks. Ensuring compliance with GCP (Good Clinical Practice), ICH (International Council for Harmonisation), and regulatory authorities' requirements. Performing quality control checks on the completeness, accuracy, and organization of documents, taking action to address any issues, and following up until corrections are completed. Preparing regular monthly study reports for the manager.

Koç University Hospital Prepares the necessary arrangements for the initiation, conduct, and completion of the clinical trial. Ensures the follow-up of patients in compliance with the study requirements and organizes their appointments. Provides patients with information about research procedures. Ensures the proper archiving of electronic and/or physical documents. Verifies data accuracy and resolves any deficiencies. Prepares for monitor visits and provides the required documents and information during inspections. Ensures the proper storage, use, and documentation of investigational drugs or devices and performs stock control. Enters data regularly and accurately. Gastroenterology, Medical Oncology, Cardiology, COVID-19 studies. Phase 1 and Phase 3

Tracking the calibration of materials used at the center and managing the proposal processes. Preparing monthly reports for calibration and informing the manager about the profit-loss ratios in the proposals.

Monitoring the operations of the Regulatory Department. Following up on operations. Organizing and managing processes. Managing the legalization procedures of documents requested by the Global Department, such as CPP and POA, and ensuring the approved documents are sent to the requested countries. Handling interactions with the Ministry for document-related requests. Ensuring Tax Office payments of the department are completed accurately and on time. Ensuring archive control. Regularly uploading and monitoring the documents of drugs in the licensing process to Veeva Vault.