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

Project Lead activity:

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.• Source Data analyzing• Source Data managing according to ALCOA rules• Project management • Strategic planning• Monthly Project Data reporting • Creating scripts/programming in Excel to expedite data processing• Metrics update communication to Sponsor team on a regular basis• Internal meeting preparation and leading• Sponsor meeting preparation and participation

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

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

Patient’s treatment and care including emergency assistance. • Patient treatment and care• Medical documentation processing• Communication with insurance company• Emergency aid providing