Clinical Operations Assistant

1 week ago


North Ryde, New South Wales, Australia Parexel Full time
North Ryde, New South Wales, Australia

Job ID R

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 wetink 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 highquality work
  • Effective problemsolving 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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