BUSRA CUBUK
Senior Clinical Research Site Coordinator
Istanbul,Kartal
Summary
Experienced site management professional with a proven track record in coordinating projects and maintaining smooth operations. Highly skilled in scheduling and coordinated, with a strong focus on team collaboration and achieving results. Adaptable to changing needs and highly dependable, leveraging effective communication and problem-solving abilities to drive success. Known for fostering a productive work environment and consistently delivering on goals. Adept at coordinating site activities and ensuring smooth project execution. Utilizes effective communication to manage teams and resources efficiently while maintaining high standards of safety and compliance.
Overview
4
4
years of professional experience
6
6
Certifications
2
2
Languages
Work History
Senior Clinical Research Site Coordinator
Veritas Clinical Research Organization
09.2024 - Current
- Oncology patient goal attainment/ Delegation to 9 active clinical trials
- SIV, DBL Proccess Different indications of oncology Phase II, Phase III clinical trials at multi-sponsor
- Facilitated communication between sponsors and regulatory authorities to expedite site initiation and trial progression, reducing average start-up time by 15%.
- IQVIA - Phase III - Small Cell Lung Cancer (2024-current)
- PAREXEL - Phase 1b-2 - Breast Cancer (2024-current)
- ICON - Phase 2b - Non-Small Cell Lung Cancer (2024-current)
- ICON - Phase 3 - Non-Small Cell Lung Cancer (2024-current)
- SYNEOS HEALTH - Phase II - Head and Neck Squamous Cell Carcinoma (HNSCC) (HPV16+)
- DAIICHI SANKYO / SYNEOS HEALTH - Phase III - Gastrıc Or GastroEsophageal Junctıon (Gej) Adenocarcinoma
- GILEAD / ICON - Phase II - Urothelial Cancer
- GILEAD / ICON REGENERON - Phase III - Melanoma
- AMGEN / PAREXEL_ Phase III- Metastatic Melanoma
Clinical Research Site Coordinator
Atlas Clinical Research Organization
06.2021 - 03.2023
- Perform all duties and responsibilities in accordance with ICH-GCP and other applicable guidelines
- Attend pre-initiation, initiation, recruitment and close-out process in trials.
- Providing support to the site team in complying with the clinical trial protocol Ethics committee file follow-up at the coordinator site for 1 year.
- NOVONORDISK - Phase III- Nephrology Diseases
- NOVONORDISK-Phase III- Endocrinology Diseases
Education
Bachelor of Science - Biomedical Engineering
Erciyes University
04.2001 -
Skills
- Strong social communication
- Manage research project databases, create flowcharts and other research-related documents, and complete research documents/case reports
- Coordinate the procurement, collection, labeling, storage, or shipment of specimens Data management and collection for clinical research projects involving patients and labs
- Maintain communication with sponsors to plan, coordinate site visits and answer questions regarding issues such as missing data
- Assembles study kits for study visits, oversees procedures, attends monitoring meetings with sponsors, and serves as the primary point of contact
- Assess participant eligibility and secure informed consent
- Workflow planning
- Organizing the space for storing work tools and materials Register protocol patients at the appropriate statistical center if necessary
- Communicate regularly with investigators to ensure patient safety and compliance with proper study conduct
- Set up research workstations and determine the availability of personnel and equipment
- Discuss with researchers the recording of adverse events, data and reporting of incidents to monitoring authorities
- Computer Skills (MS Offices, Medidata - SnapClinical Veeva Vault Almac - Square ,Clario, SnapClinical, Endpoint Longboat - Cerba, Labcorp, Q2 Solution, Suvoda, Signant Health, Almac,Firecrest,Cenduit)
Certification
ICH-GCP, 2019, 2021, 2024
Referances
Prof. Dr. Mahmut Gumus, PI
+90 506 350 90 61, mgumus@superonline.com
Senior Site Manager Betül DERECİ - Johnson&Johnson
0542 736 28 25
Senior CRA II Duygu KÜÇÜKOĞLU -MSD
0536 844 65 05
Senior CRA II Sena İkizoğlu- ICON Plc
905557108050
Senior CRA II Mervehatun Boyraz- IQVIA
+905318427940
Timeline
Senior Clinical Research Site Coordinator
Veritas Clinical Research Organization
09.2024 - Current
Clinical Research Site Coordinator
Atlas Clinical Research Organization
06.2021 - 03.2023
Bachelor of Science - Biomedical Engineering
Erciyes University
04.2001 -