Opening for Reg Records Specialist I @ INC Research
•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