Clinical operations Assistant
- Experience Level
- Experienced (non-manager)
- Track , scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.
- Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP)
- Photocopy, print distribute and retrieval of documents, as needed
- Maintain basic quality check procedures to ensure accurate maintenance of documents
- Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
- Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management
- System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines,
- International and local regulations and applicable PAREXEL procedures
- Ability to prioritize multiple tasks and achieve project timeline
- Fluent in English and French