Writer in Schaumburg, Illinois

5 years of experience in a Multi Super Specialty Hospital. Comprehensive knowledge in Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH), IND and NDA guidelines and other applicable regulations. In-depth knowledge of applicable federal regulations, institutional guidance documents and SOPs for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation. Core knowledge in preparing IRB applications, consent forms and amendments.Prepares reports and assists with statistical analysis. Knowledge in maintaining regulatory binders in accordance with FDA guidelines. Functional knowledge in preparation of all audits performed by various governing agencies. Core knowledge about Subjects’ right, safety and well-being. Comprehensive knowledge to develop and organize all critical documents related to clinical trials including data base management. In-depth knowledge in Capturing, documenting, and communicating Adverse and Serious Adverse Events information in accordance with the regulatory requirements. Knowledge on submission of trials to IRB/IEC and regulatory authorities. Functional knowledge in performing source data verification against Case Report Form/Electronic Data Capture entries Capable of Create and implement and delivering standard operating procedures confirmation and follow-up letters. Knowledge of maintaining update monthly, quarterly and annual reports of research projects Comprehensive knowledge on Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. Core knowledge in regulatory and compliance documentation including informed consents, protocol training, test article accountability, and IRB transactions. Strong knowledge of EDC systems and IVRS. Knowledge in Data Handling, Reporting, Tracking and administrative tasks.