Kardelen Özkan
Clinical Research Coordinator
Istanbul,34
Summary
I am an experienced clinical research coordinator at Istanbul (Çapa) and Cerrahpasa University Faculty of Medicine. My working process includes active participation in site audits, oversight, and sponsor co-monitoring visits. I experienced 2 different site audits in different studies, so many monitoring visits with different CRAs in different studies, oversight visit, sponsor co-monitoring visit, close-out visits, and site initiation visits.
Overview
4
4
years of professional experience
2
2
Languages
Work History
Clinical Research Coordinator
Ascot Science CRO
Istanbul, Istanbul
09.2023 - Current
- Preserving case report forms, IMP dispensation records, and regulatory documents-all of which are required for the clinical research study.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Ensuring that informed consent is appropriately obtained and documented by overseeing the enrollment of subjects.
- Tracking enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
- Capturing data on adverse events and consulting investigators on providing reports to oversight organizations.
- The eligibility of potential participants is determined by screening interviews, medical record inspections, and discussions with investigators.
- Monitoring studies are carried out to ensure compliance with appropriate institutional and regulatory guidelines, as well as established methods.
- Participating in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Recognizing issues with protocols, notifying investigators of concerns, or supporting efforts to resolve.
- Following the proposed study protocols to assess factors like data management, and sample collection procedures.
Research Intern
Izmir Institute of Technology
11.2021 - 04.2023
- Completed research, compiled data, and assisted in timely reporting.
- Completed research, compiled data, updated spreadsheets, and produced timely reports.
- Performed data entry tasks meticulously, maintaining high levels of accuracy throughout the entire dataset.
- Attended meetings and presentations to learn project details.
- Performing DNA and Plasmid Isolation
- Performing RT-qPCR, PCR and Gel electrophoresis
- Plant Tissue Culture
- MS and LB Broth Media Preparation
- Plant breeding studies
Summer Intern
Kocak Farma Solution Production Facilities
Istanbul, Istanbul
07.2022 - 08.2022
- Performing Gel-Clot Endotoxin Test
- Performing Kinetic Chromogenic LAL Assay
- Bacterial media preparation
- Obtaining swap samples
- Culturing the bacterial media and investigation
- Perform serum particle tests to solutions and record the data
- Provided administrative support to department managers, ensuring efficient daily operations within the office environment.
- Maintained a strong work ethic and positive attitude throughout the summer internship program, earning recognition from supervisors for outstanding performance and commitment to team success.
Education
Bachelor - Molecular Biology and Genetics
Izmir Institute of Technology
Izmir, 35 09.2018 - 2023.07
Skills
- Clinical documentation management
- Research sops understanding
- Safety reporting
- Ethical understanding
- Multitasking efficiency
- Therapeutic area expertise
- Time management
- Microsoft office proficiency
- Clinical documentation management
Additional Information
References:
Asligul KENDIRCI
Founder of Ascot Science
asligulkendirci@ascotscience.com
Esma OK
Senior CPM in Ascot Science
esmaok@ascotscience.com
Timeline
Clinical Research Coordinator
Ascot Science CRO
09.2023 - Current
Summer Intern
Kocak Farma Solution Production Facilities
07.2022 - 08.2022
Research Intern
Izmir Institute of Technology
11.2021 - 04.2023
Bachelor - Molecular Biology and Genetics
Izmir Institute of Technology
09.2018 - 2023.07