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Артем

Clinical research associate

Возраст:
42 года
Город:
Киев

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ARTEM CHAICHENKO
Clinical Trials
Ukraine, Kyiv
[открыть контакты](см. выше в блоке «контактная информация»)
[открыть контакты](см. выше в блоке «контактная информация»)

INDIVIDUAL SKILLS

• accuracy and punctuality
• stress resistance
• perfect time management

• teamwork commitment
• high performance orientation
• perseverance
• easy adaptation to the changeable working
conditions

WORK EXPERIENCE

Jan 2023 – Oct 2024

Project Lead/Project Analyst
KCR Ukraine (CRO)
The project data analysis and strategy planning. Implementation of trial milestones consequently according to the current protocol edition and ICH GCP E6R2 in oncology and cardiology.
• Performed project analytics tasks within 2 global clinical trials.
• Managing Project Data capture and preparing regular reports
• Supported project team with necessary data related to EDC queries, SDV progress and Study progress.
• Ensures Clinical Data quality and consistency.
• Monitoring Event Reports review – all types (Site Qualification, Site Initiation, Interim and Close-out)
• Clinical Project Management
• Strategic planning
• Monthly Project Data reporting
• Creating scripts/programming in Excel
• Metrics update communication to Sponsor team on a regular basis
• Internal meeting preparation and leading
• Sponsor meeting preparation and participation

Feb 2022 – Jan 2023

Clinical Research Associate,
KCR Ukraine (CRO)

Communication with Investigators team on-site and remotely. Site staff performance control of study protocol requirements. Data summary weekly reporting to Project Manager.

• Clinical Monitoring within 4 global multicenter clinical trials, conducted in Ukraine.
• Responsible for monitoring of 12 Clinical Sites in total
• Performed all types of Clinical Monitoring visits – Site Qualification, Site Initiation, Interim and site Close-out.
• Monitoring, co-monitoring and remote monitoring of study sites
• Preparation and conducting Investigators team meetings
• Continuous liaising with clinical Investigators on study tasks
• Regular data update and follow-up in CTMS Veeva, Clincase, Rave Medidata, Almac, Power BI, Power Query, PowerPoint, Excel, Word
• Supervising for clinical Investigation standard compliance ICH E6(R2)
• On-site/remote Source Data verification

Apr 2017 – Feb 2022

Family Physician
Communal Enterprise of Dniprovsky region (outpatient dpt)
Ukraine, Kyiv

Patients’ treatment and care of outpatient department including emergency assistance. Taking part in conducted cardiology and nephrology trials as co‑investigator and study coordinator.

• Act as co‑investigator and study coordinator during clinical trial conduct
• Patients’ treatment and care
• Clinical trial documentation processing
• Emergency aid providing
• Vaccine prevention of diseases including COVID-19

Apr 2017 – Feb 2022
Study Coordinator (Freelancer),
Synexus, Ukraine

Selection of patients for compliance and further screening in clinical trial with different nosology such as rheumatoid arthritis, Crohn’s disease, diabetes mellitus, heart failure NYHA III‑IV.
• Patients’ treatment and care
• Clinical trial documentation processing
• Communication with insurance company
• Patients’ selection and verifying eligibility criteria
• Primary Data Analysis and Monthly Reporting

Sep 2013 – Apr 2017

Family Physician
Medical Clinic “Vitalyka”, Ukraine

Patient’s treatment and care including emergency assistance.

• Patient treatment and care
• Medical documentation processing
• Communication with insurance company
• Emergency aid providing

BACKGROUND

Sep 1999 – Jun 2008
Bogomolets National Medical University
Ukraine, Kyiv
MD Family Medicine

During this period I had acquired basic education on medicine and professional internship on General Practitioner.

Sep 2005 – Sep 2008

Interregional Academy of Personnel Management
Ukraine, Kyiv

During the education period I had got basic background on main principals of business management.

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