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Clinical Trial Coordinator

2 weeks ago

Adelaide, South Australia beBeeClinicalTrialCoordinator Full time $800,000 - $1,000,000
About the Role

Clinical Trials Coordinators / Study Coordinators are required to collaborate in project teams to ensure the successful execution of clinical trials.

Reporting to the Clinical Project Manager, this role involves planning, organisation, efficient execution and monitoring of the clinical trial in accordance with the protocol, ICH/GCP guidelines and applicable regulatory guidelines and SOPs.

Please note – this is an on-site position with limited work from home scope.

Key Responsibilities:
  • Review key clinical study documentation including the Study Protocol;
  • Assist in the design and preparation of key study and source documentation;
  • Maintain the Investigator Site file;
  • Ensure that all tracking tools are updated with up-to-date project timelines and changes are communicated to relevant stakeholders in a timely manner;
  • Liaise with Clinical Research Associates to facilitate monitoring and close out visits activities ensuring all items for follow up are addressed;
  • Liaise with pharmacy and vendors relating to IP management and accountability;
  • Liaise with vendors and internal departments to ensure all study requirements and responsibilities are effectively communicated and executed;
  • Attend project meetings and study coordinator meetings to track deliverables and share best practice;
  • Participate in on-study activities as required;
  • Ensure results of protocol specified procedures and assessments are reviewed in accordance with SOPs;
  • Ensure biological samples are processed, stored and tracked in accordance with SOPs;
  • Participate in Kick Off Meetings and Site Initiation Visits as required;
  • Ensure quality control checks are performed on all documentation and that continuous improvement measures are implemented as needed;
  • Track and maintain HREC approval, assisting the Clinical Project Manager in preparing submissions and notifications;
  • Appropriate escalation of issues and protocol deviations in accordance with SOPs.