Research experience at Canadian and American universities. * Strong communication (both oral and written) and computer skills, and excellent organizational skills. * Highly motivated person, with strong analytical and problem solving skills, self-driven, but also achievement oriented team player. * Respectful of diversity KNOWLEDGE AND EXPERIENCE: Extensive research experience in Clinical trials research with adult human subjects. Knowledge of clinical trials processes and review. Extensive clinical research experience regarding clinical trials gained at the "http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/bgtd-dpbtg/centre-bureau-eng.php" Centre for Vaccine Evaluation, HC. Extensive knowledge of regulatory guidelines and procedures, including Good Clinical Practice and Drug Manufacturing Guidelines and other regulatory documentation (GxP), including ICH Guidelines. Experience and knowledge regarding evaluation and approval of biologics drugs submitted to the HC for approval. Knowledge and experience with general review/evaluation principles gained at the Health Canada. Extensive working research experience in the government (Health Canada, Centre for Biologic Research, Biologics and Gene Therapy Directorate, Vaccine Evaluation Unit) and within academic environment (University of California San Diego, University of Montreal, University of Iowa, Carleton University/University of Ottawa). Experience as a regulatory contractor in the NIH funded Islet Transplantation Consortium Clinical trial executed in collaboration with the FDA. Knowledge of bioinformatics methods, tools and resources, and various bio-databases. Knowledge of principles and applications in the area of human immunology. Knowledge of human genetics and genomics, molecular biology, biochemistry, and microbiology. Knowledge and in depth understanding of the procedures for evaluation of quality and safety of biological products and the manufacturing processes used in their production (GxP regulations and ICH guidelines understanding and usage of USP and EP). Excellent knowledge of laboratory methods and techniques used in clinical trials and quality control testing for the analysis of biological drugs. Experience in structuring, writing and in an approval process of clinical trials with biologics and primary cell transplants. Experience as regulatory coordinator in clinical trial process communications. Experience in designing technical reports and scientific papers, research projects, participating in international meetings and consultations.
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