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Job #02668

About our client Our client is a rapidly growing bio-pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various lung disease therapeutics. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location Clinical Trial Administrator Woburn, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee project and administrative tasks for one or more clinical trials 2) Support Clinical Trial Team in executing clinical trial processes from start-up through closeout 3) Coordinate purchase order generation 4) Maintain, update and distribute study contact list to the Clinical Trial Team 5) Coordinate copying, printing, distribution, assembly, tracking and shipment of clinical trial documents such as protocols, study manuals, regulatory binders, pharmacy binders, central lab supplies and all required study documents 6) Initiate and track confidentiality agreements with investigators 7) Develop and maintain project management tools, trackers and reports 8) Liaise with Clinical Trial Team to facilitate and track IRB submissions 9) Set up, organize and maintain project and central files 10) Coordinate licensure of clinical trial questionnaires and arrange for translations (as needed) 11) Arrange Clinical Team meetings and teleconferences as well as generate and distribute meeting minutes 12) Oversee supply of office resources necessary to develop study related materials Requirements 1) BS 2) Strong administrative background with experience in healthcare preferred 3) 1 – 3 years clinical research experience in a pharmaceutical, bio-tech or CRO set-up 4) Experience in clinical research or drug development a plus 5) Working knowledge of GCP, ICH and FDA regulations 6) Ability to manage multiple tasks in a collaborative environment 7) Ability to interface and communicate with Medical Team members 8) Ability to work in a fast-paced dynamic setting 9) Good attention to detail with strong problem-solving skills 10) Positive, self-motivated team player 11) Strong computer skills (Microsoft Word, Outlook, Excel, PowerPoint) 12) Excellent communication, interpersonal and organizational skills