-Creating document templates and checklists for the creation of the detailed SOPs, and TMF.-Verifying CRFs for their completion against GCP regulations-Verifying study status and progress with Datatrak eCRF type EDC/CTMS software.- Organizing the clinical research documents

-Performed data entry for phase II/III Metabolic Syndrome and LDL-C studies- verified study protocols accuracy, IB content, ICD design and CRFs completion- Enrolled patients and monitored them for three visits in Datatrak CTMS software.- Identified errors like incomplete ADR forms, using wrong version of ICF, CRF and other clinical documents and incomplete IP logs.- Resolved queries generated in the CTMS software

- Processed adverse event reports by coding in the safety database SCEPTRE besides functions like determining report type, seriousness, expectedness/labelling of adverse events, narrative writing of cases and assessing the causality of event to ensure efficient timely reporting.- Continuously updated knowledge on adverse event safety profiles of assigned drugs, reference documents, data entry guidelines, client’s procedures and safety regulations like ICH-GCP on safety and efficacy, FDA & Health Canada guidelines while working for Johnson & Johnson Canada.

- Did pre-rounds to assess the patient’s chart- continuously monitored the patient outcomes of the therapy given.- Checked the patient’s chart for various drug related problems like drug interactions, adverse reactions, and allergies.- Received and answered the queries from doctors for treating patients. - Patient counselling for discharged patients.- Patient case chart presentation to drug information centre co-ordinator.- Did thorough interview with patients on past medication, medical and social history.

Worked on RCT research project on Effect of supply of DOTS therapy by pharmacist compared to standard DOTS Centres on Patients compliance under Prof. Rajeswari Ramasamy.