Ірина

Iryna Kulakovska-Talakh
Clinical Research Coordinator / Study Coordinator
Kyiv, Ukraine | Available to work at a medical research center
Phone: [open contact info](look above in the "contact info" section)
E-mail: [open contact info](look above in the "contact info" section)

PROFESSIONAL PROFILE
Medical professional with 15 years of experience in laboratory medicine, quality control, medical documentation, and organization of laboratory processes.
Practical experience working in accordance with internal Standard Operating Procedures (SOPs), regulatory requirements, and quality management principles. Highly attentive to data accuracy, compliance with established procedures, documentation control, confidentiality, and timely completion of tasks.
Highly motivated to develop a career in clinical research and work as a Study Coordinator. Interested in developing knowledge and practical skills in GCP, clinical trial protocols, CRF/eCRF management, and communication with sponsors and CROs.
Key strengths include strong organizational and analytical skills, attention to detail, responsibility, ability to work with large volumes of information, and the ability to learn and adapt to new processes quickly.

PROFESSIONAL EXPERIENCE
Laboratory Physician
State Institution “M.M. Amosov National Institute of Cardiovascular Surgery, National Academy of Medical Sciences of Ukraine”
15 years of professional experience in laboratory medicine
Key responsibilities and achievements:
• Organization and performance of laboratory testing in accordance with approved methodologies, SOPs, and regulatory requirements.
• Management of medical documentation and laboratory test results.
• Verification of the accuracy of data entry, processing, and reporting of laboratory results.
• Verification of data accuracy and identification of potential discrepancies
• Work with quality control materials, evaluation of QC results, and analysis of deviations.
• Work in accordance with quality management system requirements and laboratory standardization principles.
• Development and updating of Standard Operating Procedures (SOPs).
• Participation in implementation and monitoring of compliance with internal procedures.
• Work with regulatory documents of the Ministry of Health of Ukraine and quality management requirements.
• Effective communication and cooperation with physicians, medical staff, and laboratory personnel.
• Compliance with biosafety requirements and procedures for handling biological materials.
• Ensuring confidentiality and protection of patient information.
• Operation of laboratory equipment and monitoring of its proper functioning.
• Analysis and systematization of large volumes of medical information.

QUALITY MANAGEMENT EXPERIENCE
• Development and updating of Standard Operating Procedures (SOPs).
• Work with quality management system documentation.
• Internal quality control.
• Analysis and evaluation of quality control results.
• Management of non-conformities and corrective actions.
• Monitoring compliance with established procedures.
• Preparation of documentation for internal quality reviews and inspections.

EDUCATION
Bogomolets National Medical University
2003–2009
Medical Faculty
Specialization: Clinical Laboratory Diagnostics
Shupyk National Healthcare University of Ukraine
Residency / postgraduate clinical training

ENGLISH
B1–B2
Motivated to further develop professional English skills for working with clinical trial protocols, documentation, and communication within the clinical research environment.

PERSONAL SKILLS
• Excellent attention to detail
• Strong interpersonal and communication skills
• Able to build positive working relationships within a team
• Responsible and reliable
• Well-organized
• Systematic approach to work
• Analytical thinking
• Ability to work with large volumes of information
• Team player
• Independent and proactive
• Fast learner
• Strong motivation for long-term professional development in clinical research