Clinical Operations Assistant

3 days ago

North Ryde, Australia Parexel Full time

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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