Clinical Trials Professional

4 days ago

Shire Of DerbyWest Kimberley, Australia beBeeResearch Full time $87,015 - $118,229
Senior Clinical Research Associate Job Description

We are seeking a highly motivated and detail-oriented Senior Clinical Research Associate to join our organization.

Job Overview:

The successful candidate will be responsible for conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation.

Key Responsibilities:

  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  • Assesses investigational product through physical inventory and records review.
  • Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.

Requirements:

  • Strong understanding of ICH-GCP guidelines, applicable regulations, and SOPs.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively as part of a global team.
  • Strong analytical and problem-solving skills.

A Day in the Life:

As a Senior Clinical Research Associate, your day will be filled with conducting monitoring tasks in accordance with the approved monitoring plan, participating in investigator meetings, and maintaining regular contact between monitoring visits with investigative sites.

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