Elizaveta Pravdina Email & Phone Number

Spain

St Petersburg, St Petersburg City, Russia

St Petersburg, St Petersburg City, Russia

Phases: III phases and bioequivalence studies.Nosologies: Cardiology, infectious diseases.My responsibilities:- I was responsible for 4 sites and conducted more than 25 visits. Patient recruitment was completed ahead of schedule in all my projects.- Working with a data management system mainEDC DM365.- Source data verification and review of completed CRFs. Managing clinical data queries based on the results of SDV.- Interaction with data managers on data entry and query resolution.- Ensuring accurate data reporting via review of site source documents and medical records. - Preparation of visit reports, follow-up letters and file notes. Ensuring that the Investigator adheres to the study protocol, current GCP guidelines and regulatory requirements.- Identify protocol deviations and risks to subject safety and data integrity. Review of the informed consent procedure and completed ICFs.- Communication with sites, investigators and sponsors. Conducting training sessions and meetings for the study team. - Ensuring timely delivery and collection of study materials and study medication to and from sites. Monitoring of biological samples transport.

St Petersburg, St Petersburg City, Russia

Phases: IIINosologies: gastroenterology, rheumatology, oncology, intensive care.My responsibilities:- Provided administrative support to more than 40 sites.- Provided support for 25 sites within one project and was responsible for submitting documents to the ethics committee and regulatory authorities.- Maintaining TMFs (including eTMF) and CTMSs (Flex Databases, Etrack)- Communication with the project team and sponsors. - Preparation of documents for delivery of study materials and study medication. Development of report forms, summary data sheets and presentations. Preparation of contracts for conclusion with investigators. Monitoring on-time payment compliance.

St Petersburg, St Petersburg City, Russia

Assisting patients with medical and pharmaceutical-related issues and providing health care counseling:- Consultation of patients on prescribed medications for medical reasons and application of over-the- counter medicines (method of taking medications, dosages, side effects and medication interactions).- Prescription verification, maintained and monitored storage conditions and systems.

Perm, Russia

Conducting preclinical studies of the substance (nootropic) on laboratory animals:- Development of methods for isolation of biologically active compound from biobjects.- Collection and analysis of preclinical data analysis of the substance. - Writing scientific articles and working with bibliographic databases.