Clinical Operations Assistant
4 weeks ago
Job Summary:
The Clinical Operations Assistant will be responsible for maintaining the Central Files for Clinical Operations, ensuring efficiency, accuracy, and quality. This role will involve tracking, scanning, filing, and entry of Case Report Forms to clients for assigned projects. The COA will also support site management team members on local billable administrative tasks and assist with quality control of Central files.
Key Responsibilities:
- Track, scan, code, and apply naming convention to documents and send them to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.
- Filing 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.
- Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery).
- Payment/invoice processing including internal follow up with payment specialists in Finance.
- Courier shipment of study document to the sites, vendor, and clients.
- Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL.
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