Preparing scientific and regulatory documents (e.g. clinical protocols, investigator’s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports). Preparing investigator/pharmaceutical company meeting minutes, analyze preclinical and clinical data, prepare reports, perform literature searches and extract information to support regulatory documents. Attending scientific meetings and reviews the literature to stay current with new developments in the infectious disease fields. Performing Protocol Regulatory Reviews.
Requirements include a M.S. degree or equivalent with 5 or more years of relevant work experience or a Ph.D. with 1 or more years of relevant work experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, or a related field; knowledge of US and non-US regulatory requirements; excellent oral, written, and interpersonal skills; high attention to detail; ability to analyze medical research data and review experimental protocols; and working knowledge of word processing, Adobe Acrobat, spreadsheet, and database management programs.
As a CRO+, TRI possesses all the essential resources to offer first-class functional and full-service outsourcing services: quality operational, strategic, technical, and regulatory solutions, long-standing clinical trial expertise, and deep therapeutic knowledge. TRI supports patient recruitment through its health communication services including design and implementation of recruitment and outreach campaigns and scientific event planning services.