Document Control Specialist
Resume:
RANDY C. SMITH
Raleigh, NC *****
919-***-**** (HOME)
OBJECTIVE: To continue as a valuable team member in a well established organization that welcomes dedication, hard work, expertise, and growth.
SUMMARY OF QUALIFICATIONS:
• Proven track record of excellent written and verbal communications skills.
• Experience in training others on standard operating procedures.
• Excellent organizational skills and adept at eliminating redundancy and improving efficiency.
• Highly focused and results-oriented in support of complex deadline-driven operations.
RELEVANT EXPERIENCE:
02/11 - present. Senior Document Control Specialist, INC Research LLC, Raleigh, NC
• Creates and maintains the document repository for all study-related documents; ensures security of documents at all times in accordance with INC Research as well as sponsors’ SOPs/WIs
• Assist with documentation preparation for all study related documents
• Receives and inventories applicable project documents
• Processes, scans, indexes, routes, and maintains files per applicable work instructions/plans/SOPs
• Participates in preparation/reconciliation of study documentation related to archival/shipping to sponsors
• Perform support tasks relating to the creation and maintenance of the document repository for all study related site documents and protocol documents pertaining to study management
• Maintains and guarantees the security and compliance of all documents related to on-going projects as well as archived documents
• Maintain security and compliance of all documents related to on-going projects as well as archived documents in accordance with relevant SOPs/WIs
• Participates in project specific training as require
• Troubleshoot and escalate issues of importance to appropriate manager(s) or director(s)
• Formatting and uploading documents in controlled electronic system for client access
01/07 – 02/10. Document Maintenance Specialist, Kendle International, Inc., Durham, NC
• Managed study trial documentation from the completion of the regulatory start-up packet
to closure.
• Assisted the Clinical Regulatory Specialists (CRS) in the initial set-up of the tracking tool
and maintained updates throughout the maintenance phase of the study.
• Processed essential documents for inclusion in the Trial Master File (TMF) and performed
audits ensuring compliance with ICH/GCP regulatory and sponsor requirements.
• Collaborated with the study team and Clinical Regulatory Specialists to ensure all trial
regulatory documents were collected and maintained in the trial master file.
• Provided training to the project team and attended study team meetings, teleconferences
and sponsored audits.
• Tracked documents in a tracking database using standardized naming conventions.
12/99 – 01/07. Document Maintenance Assistant, Kendle International, Inc., Durham, NC
• Assisted in the preparation of the project budget.
• Maintained reviews/updates for document control Standard Operating Procedures
(SOPs).
• Trained new employees on Document Control policies and procedures and assisted with
clinical support training.
• Assisted Project Managers with the identification of project-specific file set up.
• Managed acquisition activities and performed general clerical duties, i.e., filing of
documentation, creation and maintenance of project specific file structures, and ordered supplies for the file room.
• Attended relevant continuing education programs, program meetings and career
development activities sponsored by Inveresk.
02/99 – 03/99. Library Assistant, Novartis Biotechnology, Research Triangle Park, NC
• Kept the library maintained/updated with materials, refilled journals and
Bookshelves, and processed requests for articles.
• Provided general clerical support (completed requests for copies, ordered supplies for
the copier and facsimile machines, and handled/distributed the mail).
10/96 – 02/99. Customer Service Assistant, Cooper Tools, Apex, NC
• Processed mail and acted as back up receptionist to the customer service department.
• Scanned existing and new purchase orders and indexed accordingly.
• Retrieved computer faxes and distributed to customer service.
• Performed various account look up using word search machine.
08/95 – 10/96. Laboratory Assistant, Cotton, Inc., Raleigh, NC
• Conducted an analysis of cotton fiber, sliver, roving, yarn and fabric
• Analyzed the fiber selection based on the ultimate end product.
• Performed an analysis of new and/or improved varieties and qualities of U.S. cotton to
determine spinning performance.
07/94 – 07/95. File Conversion Specialist, NCNB, Raleigh, NC
• Retrieved and created new personnel files for the securities department.
• Completed data entry and copied documents based on specifications.
02/86 – 06/94. Librarian/File Clerk, Wyrick, Robbins, Yates & Ponton, Attorneys, Raleigh, NC
• Ordered periodicals and books, and approved invoice payment for the same.
• Responsible for the maintenance and update of library materials and card catalog
databases.
• Created and maintained the system for closing and storing inactive files.
• Assisted the attorneys and staff with special projects, including preparing exhibits.
• Maintained a record of litigation trials and updated the corporate minutes book.
RANDY C. SMITH
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REFERENCES: Furnished upon request
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