1.Career Objective: - To secure an internship with a Contract Research Organization (CRO) specializing in the fields of Clinical Trial/Data management. 2.Technical skills:- • Trained “Clinical Research Associate” by American Institute of Pharmaceutical Technology. • Monitor investigational sites for Qualification, Initiation, Interim and Close-out visits. • Clinical data management, Validation, Documentation and Audit activities. • Handling of Investigator’s brochure, protocol, CRF, SOP, Informed Consent & Master Files. • GCP, ICH and Protocol Interpretation and Compliance. • CRF/Source Document Verification, Database Management and Patient Profile Review. • CRA activities including field monitoring, report writing, site compliance auditing and Project Directive Follow-up. • Microbial Laboratory QC (Endotoxin, LAL etc.) tests, Drug stability (BA/BE, Dissolution) tests. • Handling of Source documents, study reports, dossiers and Coordination with sponsor. • Reporting of SAE, Coordination with sponsor and Post trial follow-up activities. • In-depth knowledge of Microbiology, Biochemistry & Biotechnology w.r.t their medical and pharmaceutical applications. • Adroit in handling common laboratory instruments (e.g. - PCR, ELISA, Spectrophotometer, Gel-doc, Centrifuge, Fermentor etc.) 3. Personal Details: Date of Birth:- ##.##.####. Languages Known: - English.