Melisa Zara
Clinical Research Associate 2
İstanbul
Summary
Accomplished Clinical Research Associate with a proven track record at IQVIA, adept in clinical data management and project leadership. Excelled in patient recruitment and protocol adherence, enhancing data quality and stakeholder communication. Demonstrated a 20% increase in study efficiency through innovative site management and meticulous clinical documentation. Accomplished Clinical Research Associate with a year of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study initiation visit .Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
4
4
years of professional experience
Work History
Clinical Research Associate
IQVIA
03.2023 - Current
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Clinical Research Coordinator
INNOVEX
03.2022 - 03.2023
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Coordinator
MENE Health Group
01.2021 - 11.2022
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Coordinator
Atlas CRO
09.2020 - 01.2021
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Education
Bachelor of Science - Bioengineering
Istanbul Bilgi University
Turkey 04.2001 -
Skills
Project Management
Site Management
Patient recruitment
Clinical Data Management
Clinical Documentation
Languages
Turkish
Native language
English
Advanced
C1
Awards
- IQVIA Impact Awards 2023
- IQVIA Impact Awards 2024
Timeline
Clinical Research Associate
IQVIA
03.2023 - Current
Clinical Research Coordinator
INNOVEX
03.2022 - 03.2023
Clinical Research Coordinator
MENE Health Group
01.2021 - 11.2022
Clinical Research Coordinator
Atlas CRO
09.2020 - 01.2021
Bachelor of Science - Bioengineering
Istanbul Bilgi University
04.2001 -
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