- Participate in multi-national project teams, ensuring exceptional customer service on complex studies.
- Conduct site selection, initiation, monitoring, and close-out visits to ensure regulatory compliance.
- Collaborate with the Regulatory team to obtain approvals from Ethic Committees (ECs) and Health Authorities (HAs).
- Evaluate site practices for quality and integrity according to Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and local regulations.
- Bachelor's degree in life science or other scientific discipline.
- Minimum two years of on-site monitoring experience or equivalent combination of education/training/experience.
- Knowledge of applicable clinical research regulatory requirements (GCP/ICH guidelines).
cra/scra - Centro - Pivotal
Descrizione
Pivotal is expanding its team and seeks an experienced Clinical Research Associate to deliver clinical research excellence.