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Job #02492

About our client Our client is a privately held company with the highest ethical and quality standards. Founded in early part of this century, the company provides high quality biological information and material and caters to the urgent need of genomics and proteomics researchers. It also provides relevant information and material that are needed to conduct research on common disease targets such as cancer, heart disease and brain disorders. Position Location Clinical Program Manager Michigan Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure that company-sponsored studies are operating with appropriate ethical guidance (e.g., IRB approval, informed consent) 2) Interact with a variety of laboratory and clinical researchers within company’s global network of study sites 3) Schedule and complete audits of clinical sites (i.e. 50% working time) 4) Coordinate (with Principal Investigator) submission of study status reports with Principal Investigator for continuing IRB approval 5) Draft and distribute audit reports 6) Coordinate (with Principal Investigator) submission of new protocols to IRB 7) Define local business processes and policies to ensure success of objectives 8) Maintain study document files for network of study sites 9) Involve in defining new policies and procedures for the company 10) Coordinate (with Principal Investigator) protocol deviation reports to IRB Requirements 1) BA/BS 2) Minimum 4 – 5 years of experience as Clinical Research Associate or Clinical 3) Trial Monitor 4) Completed training in CFR Title 21 GCPs and ICH GCPs (CCRA preferred) 5) Familiar with a wide range of human diseases, genomics/proteomics and anatomic pathology 6) Tissue growth experience 7) Proficiency in MS Office software programs 8) Excellent communication skills – written/verbal 9) Good interpersonal and problem-solving skills 10) Superb attention to detail 11) Willingness to travel – up to 50%