レコード・マネジメント・アシスタント Records Management Assistant - CareerCross - 2015
This position will be responsible for maintaining the paper and electronic documents for the electronic Trial Master File (eTMF) in accordance with regulatory, legal, and other relevant guidelines.
• Store and retrieve documents as necessary from archive or long term storage.
• Utilize electronic imaging and quality-control management applications to maintain the electronic trial master file in compliance with Good Clinical Practices and other relevant guidelines.
• Assist the business with the migration of paper documents into the eTMF system.
• Perform Audit Ready Check reviews in eTMF for an eTMF Specialist as necessary.
• Maintain document quality standards and quality check document attributes for completeness and accuracy.
• Perform various other document management tasks using the appropriate hardware and software and assist with projects as required.
• Build knowledge of current status for multiple projects simultaneously pertaining to aspects of records management.
• Maintain the filing records to enable quick retrieval of documents.
• Assist with training others, both formally and informally.
Education
Minimum Required:
• Associate’s (2-year) Degree with a’ Life Sciences/Business focus.
Preferred:
• Bachelor’s (4-year) Degree with a Life Sciences/Business focus.
• Equivalent experience within clinical research environment of 5+ years may be substituted for education requirements.
Experience
Minimum Required (at least one or more of below):
• Minimum 1 years’ experience working in a records management environment; or equivalent combination of education, training and experience.
• Knowledge of Regulatory/Clinical documents.
• Familiarity with record retention requirements for the pharmaceutical industry.
• Experience working in clinical electronic systems.
• 1+ years of experience working with clinical trial documentation.
Preferred:
• Understanding of ICH/GCP guidelines.
Other
• Ability to work independently.
• Extensive knowledge of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
Company Description
世界の製薬会社をクライアントに持ち、研究施設を各国に保有する米国ＣＯＶＡＮＣＥ社。前臨床実験の分野では世界シェアトップクラスのリーディングカンパニーです。 その日本法人であるコーヴァンスジャパン株式会社は2004年に設立され、日本の製薬企業企業へ新薬開発の為の臨床・非臨床実験の受託、研究・コンサルティングを提供しています。 Covance is one of the world’s largest and most comprehensive drug development services company with annual revenues greater then US$1.5billion, global operations in more than 20 countries and more than 10,000 employees worldwide. Covance is a world-class provider of the following service lines:
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