Clinical Research Specialist

Preparation of the Summary of Product Characteristics. Package leaflet, checking documents regarding conducted user testing. Package leaflet, preparation of literature reviews of clinical data. Conducting CI monitoring, writing reports on CI monitoring results, writing the Clinical Study Final Report; Clinical study monitoring, including checking source documentation, ICF and investigator file, preparation of reports based on monitoring visit results; Writing final reports on conducted clinical studies; Preparation of the document package for clinical centers (Principal Investigator file, IEC file, as well as ICF and patient informed consent in the required quantity) Development of IMP (SmPC) and SPC of medicinal products; Preparation of literature reviews on clinical studies. Compliance with information confidentiality

Requirements

Higher medical or pharmaceutical education; Possession of a GCP certificate is welcome; English language proficiency B2; Experience in clinical studies is welcome; Responsibility, diligence, punctuality

Higher education — specialist degree, master's degree; Experience: 1 year

Conditions

Optimal