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Global drug and device development services

Clinical Research Associate 2 / Senior Clinical Research Associate

Clinical Research OperationsPosted on Nov 13
Full-timeRemote in AustraliaNo salary listed

About the Job

Requirements

  • A relevant life sciences, healthcare, or clinical research qualification, or equivalent relevant clinical research experience, is required.
  • At least 2 years of experience as a Clinical Research Associate is required.
  • In-depth knowledge of clinical trial processes, regulations, and ICH Good Clinical Practice guidelines is required.
  • Knowledge of ICH Good Clinical Practice, clinical trial conduct, and site monitoring requirements is required.
  • Practical experience with site monitoring or site management appropriate to the role level is required.
  • Experience performing site qualification, initiation, monitoring, and closeout activities is required.
  • Experience verifying protocol, GCP, and regulatory compliance and participant protection is required.
  • Willingness to travel as required, approximately 60%, is required.

Responsibilities

  • Perform site qualification, initiation, monitoring, and closeout activities as assigned.
  • Contribute to clinical trial monitoring activities and take responsibility for assigned deliverables while working collaboratively.
  • Verify protocol, GCP, and regulatory compliance and participant protection.
  • Review source data, essential documents, and site processes for accuracy and completeness.
  • Identify and follow up findings, risks, and corrective actions.
  • Maintain clear communication with investigators, site staff, and study teams.

Desired Qualifications

  • Therapeutic area expertise relevant to assigned studies is preferred.
  • Experience with risk-based monitoring or centralised monitoring approaches is preferred.
  • Experience with clinical trial management systems (CTMS), electronic data capture (EDC), and electronic trial master file systems is preferred.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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