Senior Clinical Research Associate I (FSP)

Thermo Fisher Scientific · Malaga, Australia

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Role summary

Senior Clinical Research Associate I coordinates clinical monitoring and site management activities for Thermo Fisher Scientific's PPD clinical research portfolio. The role involves conducting remote and on-site visits to assess protocol compliance, managing documentation, and ensuring investigational sites operate according to ICH-GCP guidelines and regulatory requirements.

What they're looking for

Bachelor's degree in life sciences or Registered Nursing certification with equivalent qualification
Approximately one year clinical research monitoring experience or comparable background
Proven clinical monitoring skills and understanding of ICH-GCP guidelines
Critical thinking, root cause analysis and risk-based monitoring expertise
Strong oral and written communication and medical terminology knowledge
Ability to manage documentation and regulatory compliance across multiple trial requirements

What you'll be doing

Monitor investigator sites using risk-based approach; conduct SDR, SDV and CRF reviews via on-site and remote activities
Identify and assess investigational product through inventory and records review; document findings in compliance reports
Initiate clinical trial sites, conduct investigator meetings and perform trial closeout activities
Ensure crucial documents are complete per ICH-GCP standards; provide trial status reports to Clinical Team Manager
Facilitate communication between investigative sites, client company and project team; respond to regulatory audits and inspections

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Date posted10 days ago

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