Position Summary
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
Qualifications:
Education: High School Diploma