Highlights:

Skills:Clinical Trials o Conducting Online and retrospective audits of on going and completed trials. o Checking of CRF and other documentations of trial. o Ensure adverse events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary. o Preparation of Audit plans, checklists and audit reports. o Auditing ongoing trial and trial related documents. o EC submissions. o Auditing final reports. o GCP compliance and applicable regulatory guidelines compliance. o Training of trial staff. o Conducting training programs. o Visiting trial sites as and when required. Bioequivalence Studies o Preparation, review and implementation of SOP’s. o Review of the clinical protocol, CRFs and ICFs. o GCP compliance and applicable regulatory guidelines compliance. o Review of the clinical raw data and compiled reports. o Reviewing of the final reports. o Facility audit of the clinical section.

Clinical Research Associate