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Clinical Operations Assistant
1 week ago
North Ryde, New South Wales, Australia
**Job ID** R0000023529
**Category** Clinical Trials
**ABOUT THIS ROLE**:
*Good understanding of assisting and supporting Clinical Operations tasks/ inhouse works*
*Office based*
*Will be hiring as Direct Contractor with 1 year period of employment (12 months) > During this period of the contract, may consider training for transition to the CRA role (as demonstrated by performance in the COA tasks and training)*
Project Trails Master File
- Filling and Archiving paper wet-ink documents in the Central Files office location as per the Trial Master File plan
- Photocopy, print, distribute and retrieval of documents, as needed
- Support on creating and review of Note to Files (NTF)
- Maintain basic quality check procedures to ensure accurate maintenance of documents
- Review/update TMF country and site issues in 30 days
- Review/update EDL (Essential Documents List)
- Review/update TMF milestones
- Clear QC stops (if applicable)
- Follow up with sites regarding pending documents
- Transfer of documents to sponsor TMF systems (if applicable)
- Vendor Management
Track and manage vendor communication related to site staff access to systems (e.g. EDC, IVRS) during activation
- Follow up with sites
- Study specific completion training
Payment Support
- Review if Site payments funds are completed as per site contracts and follow up with responsible team accordingly
Support to all local site management team members (CRA, iCRA, COL, SSUL)
- Skills:
- 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
- Good oral and written communication skills to internal and external customer
- Flexibility to perform multiple tasks and ability to prioritize these to achieve project timeline
- High commitment to and performs consistently high-quality work
- Effective problem-solving skills
- Mentor and train less experienced staff as appropriate
- Active participant as a process and/or platform Subject Matter Expert (SME) with mínimal LM oversight
- Demonstrate attitude, teamwork, proactiveness and confidence
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