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• Completion of Study Master File Index (SMFI) • Coordinate all translations • Documentation – Receive and process (upload, assigning of attributes, filing, review and approval of subset of documents in CDC) required regulatory, legal and financial documentation in order to ensure successful study start-up (e.g. site initiation visits, product shipment, start of patient enrolment) following WI. • Receipt of core trial documents from all clinical functions and file in accordance with SMFI • Assembly & distribution of mass communications (MOP, Study Tools, Newsletters, Annual Reports) • MUL Maintenance • Provide support on the coordination of Investigator Meetings • Reconcile site training files • Support with IRB / EC / CA packet preparation • Order, assembly and distribution of Study Support Materials • Maintain team roster • Manage site/contact/study information on appropriate tool • Contacts outside vendors for supplies, arranging for photocopying of materials, tasks handling for binder assembly and shipping. • Review Financial Disclosure Form for potential conflict of financial interest • Maintains good knowledge and understanding of departmental procedures and other requirements as required; keeps all procedure training up to date. • Performs miscellaneous administrative tasks as required. • Receives, inventories, and initiates shipments of investigational products according to regulatory and company guidelines. • May be required to be on call at times to provide support to ship investigational product, documents or any other required material. • May be required to perform other duties when assigned REQUIREMENTS FOR THIS POSITION: Minimum Education & Experience: Bachelor’s-level degree preferred or equivalent through experience. Competency Expectations: • Good verbal and written English communication skills. • Excellent interpersonal and organizational skills. • Detail oriented and good problem solving ability. • Ability to work on teams and with multiple projects. • Excellent computer skills (experience with spreadsheets and word processing programs). Working Conditions: Office environment. Potential exposure to blood borne pathogens and other potentially infectious materials (Only applicable for Brussels office). |
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简单回复
abczhang5楼
2012-05-14 16:06
小鱼海角(金币+1): 谢谢参与
