Asena Ekinci, M.Sc.
Clinical Research Associate
Istanbul
Summary
With a solid background in molecular biology, genetics, and regenerative medicine focused on human afflictions, I bring robust educational and practical experience, including clinical trial management and site monitoring at hospitals. I excel both independently and collaboratively, demonstrating strong communication and interpersonal skills. My commitment to continuous learning and tackling challenges underscores my confidence in making a significant impact in science and human health.
Overview
8
8
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Jr. Clinical Research Associate
Rosenbaum Group CRO
02.2024 - Current
- Conducting site selection, initiation, monitoring, and close-out visits
- Assisting in developing a subject recruitment plan
- Assessing site practices for quality and compliance with regulatory standards such as GCP and ICH guidelines
- Monitoring progress through tracking regulatory submissions, recruitment efforts, completion of case report forms, and resolution of data queries
- Performing ongoing reconciliation of the Trial Master Files (TMF) content to site files
- Ensuring all documentation and records are organized and up-to-date
- Collaborating with team members to address any potential issues or discrepancies
- Facilitating communication and knowledge-sharing between global teams
- Collaborating effectively across the company's branches in different countries
- Assisting in preparing documentation and records for audit readiness
- Collaborating with internal teams and stakeholders to prepare for the audits
- Collaborating with study site experts and client representatives
In-House Clinical Research Associate
Rosenbaum Group CRO
12.2023 - 02.2024
- Collaborate with management to ensure adherence to standard protocols and regulatory obligations, including ICH GCP, in assigned clinical site monitoring activities
- Collect documents and review data entries and findings in Electronic Data Capture (EDC) systems and files
- Evaluate and escalate site performance and quality indicators appropriately
- Write, track, and resolve clinical queries and issues
- Support investigator recruitment efforts using phone scripts, questionnaires, study site materials, and other assessment tools
- Record site management interactions according to the monitoring plan
Stem Cell Treatment Coordinator
Turkishdoc
2 2023 - 12.2023
- Developing and maintaining detailed protocols for stem cell therapies, considering ethical and regulatory guidelines and ensuring adherence to standard operating procedures
- Collaborating with healthcare providers to identify and recruit suitable patients
- Consulting patients about their treatment
- Improving marketing strategies regarding regenerative therapy
- Tracking, reviewing, and reporting progress and results of marketing content regarding stem cell research
- Writing and publishing high-quality research-based content about regenerative medicine and stem cell applications on diseases and conditions
Scientific Consultant
VBB Gentek Stem Cell Treatments
10.2021 - 02.2023
- Writing high-quality reports, preparing high-quality abstracts and presentations and summarizing translational and clinical research data and regulatory documentation for autologous and allogeneic stem cell applications for treating patients
- Linking preclinical research activities to clinical development projects
- Contributing to the identification of new opportunities for VBB Gentek’s pipeline and technology development through literature and database searches, and by keeping up to date with the field of autologous and allogeneic stem cell applications
- Creating consultative advice for the project teams when called upon
Clinical Application Specialist
Apaz Medikal
05.2021 - 10.2021
- Training laboratory personnel, clinicians and physicians to implement clinical imaging and applications through patients
- Conducting product training and application support in on-site hospital settings or via web session for healthcare professionals
Master Thesis Researcher
Max Delbrück Center
03.2019 - 09.2019
- Master Thesis: “Generation of motor neurons with precise anterior-posterior identity from human pluripotent stem cells to study neuromuscular diseases”
- Gathering and organizing information for research purposes
- Performing research into neuromuscular system and diseases to increase knowledge and to provide valuable contributions
- Collaborating with leadership team to identify relevant questions and determine best methods of collection
- Learning new laboratory techniques and applied expertise in carrying out enhanced experiments under supervision of senior lab members
Research Assistant
Universitätsklinikum Carl Gustav Carus
05.2018 - 03.2019
- Project: “Establishment of HDR-mediated CRISPR/Cas9n gene editing for in vitro disease modeling of Amyotrophic lateral sclerosis using HEK293T and human-specific iPSC lines”
- Managing lab responsibilities including preparing reagents, monitoring consumable spendings
- Performing statistical, qualitative, and quantitative analysis
- Working both independently and collaboratively in fast-paced laboratory environment
- Attending seminars and symposiums to improve overall knowledge and understanding
- Gathering, arranging, and correcting research data to create representative graphs and charts highlighting results for presentations
Research Assistant
German Center For Neurodegenerative Diseases
04.2018 - 02.2019
- Project: “Investigation of time-dependent effects of TNF-alpha on human neural stem cell plasticity and neurogenic capacity in 3D hydrogels to study Alzheimer's disease"
- Learning genome engineering techniques: molecular cloning, CRISPR/Cas9 gRNA design, PCR
- Managing lab responsibilities including preparing reagents, monitoring consumable spendings
- Working both independently and collaboratively in fast-paced laboratory environment
- Performing qualitative, and quantitative analysis
- Maintaining up-to-date records of research activities and results for future reference
Research Assistant
Technische Universität Dresden
10.2017 - 03.2018
- Project: “Aging effects on gene expression and neural stem cell proliferation in adult zebrafish brain”
- Utilizing advanced analytical software to analyze data sets
- Performing statistical, qualitative, and quantitative analysis
Intern
Koç University Hospital
06.2016 - 07.2016
- Project: “Identification of mutations in patients being suspected of Familial Mediterranean fever disease”
- Sorting and organizing files, spreadsheets, and reports
- Completing research, compiled data, updated spreadsheets, and produced timely reports
- Analyzing problems and worked with teams to develop solutions
Education
Master of Science - Regenerative Biology And Medicine
Technische Universität Dresden
Dresden, Germany 10.2017 - 09.2019
Bachelor of Science - Genetics And Bioinformatics
Bahçeşehir University
Istanbul, Turkey 09.2012 - 06.2017
Vocational Training Certificate - Business Administration And Management
International University of Applied Sciences
Berlin, Germany 07.2016 - 08.2016
Skills
Clinical Trials
Questionnaire Development
Research and Analysis
Study Design and Protocols
Research Reporting
Data Entry
Database Search and Maintenance
Patient Recruitment
Good Clinical Practices
Informed Consent
Schedule Coordination
Laboratory Techniques
Stem Cells
Organization and Time Management
Flexible and Adaptable
Multitasking Abilities
Teamwork and Collaboration
Languages
English
Proficient
C2
German
Upper intermediate
B2
Turkish
Proficient
C2
Certification
Goethe-Institut e.V. Deutsch Online B2 Level
Timeline
Jr. Clinical Research Associate
Rosenbaum Group CRO
02.2024 - Current
In-House Clinical Research Associate
Rosenbaum Group CRO
12.2023 - 02.2024
Goethe-Institut e.V. Deutsch Online B2 Level
12-2022
Scientific Consultant
VBB Gentek Stem Cell Treatments
10.2021 - 02.2023
Clinical Application Specialist
Apaz Medikal
05.2021 - 10.2021
Master Thesis Researcher
Max Delbrück Center
03.2019 - 09.2019
Research Assistant
Universitätsklinikum Carl Gustav Carus
05.2018 - 03.2019
Research Assistant
German Center For Neurodegenerative Diseases
04.2018 - 02.2019
Master of Science - Regenerative Biology And Medicine
Technische Universität Dresden
10.2017 - 09.2019
Research Assistant
Technische Universität Dresden
10.2017 - 03.2018
Vocational Training Certificate - Business Administration And Management
International University of Applied Sciences
07.2016 - 08.2016
Intern
Koç University Hospital
06.2016 - 07.2016
Bachelor of Science - Genetics And Bioinformatics
Bahçeşehir University
09.2012 - 06.2017
Stem Cell Treatment Coordinator
Turkishdoc
2 2023 - 12.2023