Clinical Research Associate

1. Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collecting the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.

2. Site selection and qualification evaluation under supervision of senior personnel.

3. Assist during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirements.

4. Collecting all ECs requirements per allocated studies.

5. Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.

6. Monitoring and quality control of the work of investigational sites; planning and performing

monitoring visits in accordance with GCP and the study protocol and guidance. Strictly follows everything stipulated under ICH-GCP, point 5.18.

7. Reviewing and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.