Clinical Trial Integrity Specialist

11 hours ago

Brisbane, Queensland, Australia beBeeCompliance Full time $73,000 - $105,010

Monitoring Specialist

The Clinical Research Associate (CRA) is a monitoring specialist responsible for ensuring the integrity of clinical trials. This involves conducting remote or on-site visits to assess protocol and regulatory compliance, managing required documentation, and ensuring audit readiness.

Key Responsibilities:

  • Identifies site processes failures and applies root cause analysis, critical thinking, and problem-solving skills to implement corrective/preventive actions.
  • Ensures data accuracy through source document review, onsite and remote monitoring activities, and standard operating procedure compliance.
  • Conducts physical inventory and records reviews, documenting observations in reports and letters using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management promptly and follows all issues through to resolution.
  • Maintains regular contact with investigative sites between monitoring visits to ensure compliance with the protocol, previously identified issues are being resolved, and data is recorded in a timely manner.

About Our Work:

We deliver life-changing therapies by providing resources needed to achieve individual career goals while advancing science through research, development, and delivery.

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