69.00€
Clinical study must be monitored as per the ICH GCP and local requirements. Clinical Research Associates (CRAs) are responsible for the sites monitoring based on the Clinical Monitoring Plan (CMP) prepared in the study set-up phase by the Project Manager, Clinical Trial Manager or designee as described in the relevant SOPs. Course on introduction to planning and performing of monitoring visits allows to understand the purpose and importance of clinical trial monitoring and how the visits should be planned by a CRA to ensure the CMP requirements are met. During the course we will define what are the requirements for being a CRA and how this should be documented. Course is focused also on the different types of monitoring visits and explains the key project milestones. After completion of the course, participants will understand where to find information about monitoring visits requirements, what are the important SOPs, how to use a CMP and what information can be found there. The main focus during the course is put on the visits planning at the different stage of the study and escalation of the CMP non-compliance. Participants will be provided with a real-life example of the CMP instructions and situations when visits planning is problematic. Course is followed by several exercises such as questions bank, knowledge check, case study. By completion of the course, participants will gain the knowledge which is needed to understand further aspects of clinical trials monitoring.
Excellent communicator with can-do attitude and strong desire to learn. Project Manager with line management responsibilities focused on quality. Currently fulfilling the role of an Oversight Portfolio Manager working on a governance level, responsible for several studies of one client and oversight and support a group of CTMs allocated for those projects. Client oriented and dedicated team player. Long-term goal is to have an independent and responsible position as a global project director. Experience in pharmaceutical marketing, medical affairs and clinical trials gained in pharma companies and CROs.Founder and member of Polish Pharmaceutical Students’ Association. Member and head of the training group at Polish Association for Good Clinical Practice (GCPpl). Pharmacist with strong interest in clinical pharmacy. Academic teacher delivering lectures related with clinical trials.
Certificates: Soft Skills Trainer Certificate, Prince2 Foundation Training Certificate, Barnett GCP Certificate. Laureate and winner of a 3rd place of the national competition “Leaders of Clinical Trials (2021)” in the category Project Manager. Scholar of Leslaw A. Paga Foundation in the program “Healthcare Leaders”.
Privately foodie and enthusiast of cooking, travelling and fantasy books.
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