INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Post : Reg Records Specialist I
•Adheres to project-specific data tracking guidelines and relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).
• Receives and inventories applicable project documents, e.g., Trial Master File Documentation, Investigator File Documentation, Case Report Forms (CRFs), Data Clarification Forms (DCFs), and/or Data Management Files.
• Processes, scans, indexes, routes, and maintains files for CRFs, DCFs and data management documents in accordance with SOPs/WIs.
• Maintains the security and compliance of all documents related to ongoing projects and archived documents in accordance with relevant SOPs/WIs.
• Responds timely to requests for site documents, pulling and re-filing site documents; ensures applicable paperwork is completed upon release from and returned to the Document Control Room.
• Participates in preparation/reconciliation of site documentation related to archival/shipping to sponsors.
• High school education or equivalent.
• Some experience in a clinical trials environment preferred.
• Strong knowledge of all applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
• Strong verbal, written, and organizational skills with a team-oriented approach.
•Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Industry Type: Pharma
Functional Area: Document Control
Last date: 10th December, 2016
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