
Novotech is a global full-service clinical Contract Research Organization (CRO) with headquarters in Sydney, Australia.
Performing site evaluation, initiation, monitoring and close-out visits, plus maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP, and applicable regulations. Supporting the development of a subject recruitment plan. Establishing regular lines of communication plus administering protocol and related study training to assigned sites. Evaluating the quality and integrity of site practices - escalating quality issues as appropriate. Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.