1) Reviews all EC submissions/notifications and facilitates prompt and correct completion by the Investigator. Reviews all EC approvals and correspondence for completeness and adherence to ICH GCP requirements.
2) Conducts IP accountability.
3) Reviews completion of all protocol related procedures/assessments by the responsible Investigators, which would include scheduling, subject screening and enrolment
4) Prepares for and assists at site initiation visit, interim monitoring visits and the close out visit
5) Responsible for the efficiency of the workflow in study activities including CRF or eCRF completion,
6) Query resolution, maintenance of Investigator Site File and other trial rel...
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