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Responsible for monitoring and managing the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP), Study Specific Procedures (SSP), and applicable regulatory requirements.
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.
Assist of country and/or site start up activities, including but not limit to country/site ICF development, preparation of IRB submission package, site contract and budget negotiation, and regulatory documents collection.
Perform the tasks assigned by line manager.