Elżbieta Saja

- Local Trial Manager,
- Phases of trials: Hematology IIb, Psychiatry III, Nephrology IV, Reumatology III,, Cardiology III, Diabetology III.

- Monitoring activities such as:
- Identifying qualified investigators for clinical trial (Feasibility Process)
- Budget planning for the trials, budget control during the study, signing contracts with investigators,
- Submissions the trials to Health Authority and Ethics Committee
-Performing Initiation Visits, Monitoring Visits, Closure-out Visits,
-Patients’ related documents preparation,
-Supervision over the other monitors within the study.
- Accurately tracking of study progress,
- EDC trainer for the study team,
- Preparing requests for payments to vendors and investigators.

Participating in sites selection and qualification process. Attending some qualification visits. Preparing reports from visits. Preparing registration documentation for Polish Regulatory Authority and Ethics Committees. Collecting necessary site’s documents such as CVs, FDA1572 forms, FDFs. Preparing study files, Giving support for monitors in administrative activities in clinical trials. Participating in monitoring visits. Responsibility for drug accountability. Preparing contracts and negotiating their conditions with investigators and institutions.

Providing support to monitors in performing clinical trials. Cooperation with Polish Health Authorities in the field of registering new trials in Poland (preparing application forms and all required documents). Submission of documents to Ethics Committees, collaboration with the Customs Committee regarding importation and customs clearance of the study medicines, laboratory kits, devices and other trials related shipments.

Supporting managers in performing business projects. Keeping control over payments, issuing invoices on the clients. Responsibility for preparing the financial statements and reports. Co-operation with the biggest Polish banks over the consolidation process.

Supporting monitors in performing clinical trials, registration of the clinical trials in Polish Health Authorities, organizing start-up meeting, congresses.