Clinical Research Project Manager

1 week ago

Sydney, New South Wales, Australia beBeeResearch Full time $70,000 - $90,000
Job Overview

The Clinical Research Coordinator is a critical team member responsible for the successful execution of clinical research projects. This role involves various tasks, including communication with project team members, maintaining documentation as per protocols and regulatory standards, and ensuring timely production of high-quality clinical data.

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  • Key Responsibilities:
  • Document and track study activities using relevant forms and tools with minimal guidance.
  • Assist in the preparation of study and site-specific materials according to relevant SOPs.
  • Complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
  • Create and maintain tracking systems/spreadsheets for study supplies.
  • Support Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
  • Provide support to project teams (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax, and photocopy documents, assemble study documents, and arrange meetings).
  • Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable.
  • Audit and CAPA tracking.
  • Set up and maintain clinical investigator files and documentation.
  • Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
  • Coordinate and plan study supply shipments with vendors.
  • Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders).
  • General communications to sponsors, sites and internal team members via electronic mail or courier or telephone.
  • Perform other administrative duties.
  • Train and mentor less experienced Clinical Trial Administrators.
  • Liaise with other departments to ensure project delivery.

Requirements:

  • Associate degree or equivalent.
  • Relevant clinical research experience in pharmaceutical or CRO industries may be considered in lieu of educational requirements.
  • Speaking, writing, and reading proficiency in English and local language.

Preferred Skills:

  • Strong organizational and time management skills.
  • Computer literacy (Microsoft Office Suite: Word, Excel, PowerPoint).
  • Critical thinking and problem-solving.
  • Good typing skills.
  • Good spelling and proof-reading skills.
  • Ability to operate standard office equipment.

Work Environment:

  • Office based in Sydney.

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