Clinical monitoring (CRA)
A Clinical Research Associate since 2000, I give sponsors rigorous oversight of their sites, from phase I to phase IV, in line with the protocol, procedures and source documents.
- Site selection, initiation, monitoring and close-out visits, on site or remote, as defined in the monitoring plan.
- Informed consent and eligibility review.
- Source data verification and review (SDV/SDR) against the eCRF, query management.