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| Job Title: |
Document Control Specialist |
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Job Location:
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Raleigh - North Carolina - USA |
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Job Category:
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Data Management
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Job description:
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Performs support tasks relating to creating and maintaining the document repository for all study related regulatory documents, site documents and protocol documents pertaining to data management and clinical study.
1. Creates and maintains the document repository for all study-related data management and clinical study documents.
2. Receives and inventories applicable project documents, e.g. Case Report Forms (CRFs), regulatory documents, Data Clarification Forms (DCFs), etc. data management files and clinical study documents.
3. Processes and routes CRFs/regulatory documents per applicable work instructions.
4. Maintains and guarantees the security and compliance of all documents related to on-going projects as well as archived documents in accordance with relevant SOPs/WIs.
5. Responds timely to requests for study specific documents, pulling and re-filing CRFs; ensures applicable paperwork is completed upon release from and return to the Document Control Room or Trial Master File Room.
6. Participates in preparation/reconciliation of files for sponsor; QA Audits, and/or CRFs and documentation related to archival/shipping to sponsors.
7. Participates in project specific training as required.
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Skills:
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Requires a high school education or equivalent. Some college courses in the scientific/regulatory field plus a minimum of one year experience in a clinical trials environment preferred. Strong knowledge of FDA regulations and guidelines with respect to regulatory documents and familiarity with medical terminology is necessary. Requires good verbal, written, and organizational skills with a team-oriented approach. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Proficiency in Microsoft Office Suite and email is required. |
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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High School |
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Experience (year):
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1 |
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Post Date:
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09/07/2008 |
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| Contact Information |
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Address:
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<a href="http://trials.in.ua">clinical research</a> 01033 - Ukraine |
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