Duties:

• Provide documentation, including but not limited to invoices, and time recording at the direction of Senior Associate Director, or designee.
• Support the Regulatory Affairs team in Duluth to ensure materials in Regulatory Archive are processed correctly and in compliance with procedures.
• Properly index all local material  according to appropriate standards.
• Locate and Transfer contents of CDs to an electronic file located in the Client's Central folder (TBD)
• Perform OCR (Optical Character Recognition) on scanned files and CD contents as needed.
• If applicable after OCR, verify destroy the hard copy files or CDs.
• If the above is completed, then scan and process files
• Manage the Chain of Custody procedures to ensure the integrity of all study documentation.
• Performs other duties as assigned.

Skills:

• Professional knowledge of MS Programs and Adobe Acrobat
• Demonstrated ability to multi-task and juggle competing priorities in a passionate, positive and professional manner
• Demonstrated ability to comply with all company procedures and processes, especially in regard to compliance
• Outstanding flexibility, adaptability and sense of accountability 
• Self-starter and works independently