Clinical Research Associate

2 weeks ago


Gold Coast, Queensland, Australia Pharmiweb Full time
Job Summary

We are seeking an experienced Clinical Research Associate to join our team at Pharmiweb. As a Clinical Research Associate, you will be responsible for clinical monitoring activities, site relationships, and study site management in accordance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, and Protocol.

Key Responsibilities:

  • Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
  • Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
  • Gain an in-depth understanding of the study protocol and related procedures.
  • Perform remote and on-site monitoring & oversight activities.
  • Conduct site visits including validation visits, initiation visits, monitoring visits, close-out visits, and record clear, comprehensive & accurate visit & non-visit contact reports.
  • Collect, review, & monitor required regulatory documentation for study start-up, study maintenance, & study close-out.
  • Communicate with Investigators & site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
  • Support & lead audit/inspection activities as needed.
  • Manage & maintain information & documentation in CTMS, eTMF, & various other systems as appropriate & per timelines.


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