Senior Clinical Research Associate, Apac

Boston Scientific Foundation Inc

Taipei City, TW
On-site
Risk-based monitoring strategy
Site compliance oversight
Protocol analysis for risk management
Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements

Job Summary

  • Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
  • The role of Senior Clinical Research Associate as a Lead Monitor is responsible for the compliance and oversight of clinical trials that implement a Risk-Based Monitoring (RBM) strategy and being the main point of contact between the study team and site monitors.
  • As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.

Matching Summary

Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.

Skills & Requirements

Must-have

  • Risk-Based Monitoring strategy
  • site compliance oversight
  • protocol analysis for risk management
  • source document verification
  • regulatory documentation review
  • event reporting and documentation

Nice-to-have

  • mentor less experienced staff
  • work across cultures
  • problem-solving skills
  • establish effective working relationships

Key Requirements

  • Bachelor’s degree or equivalent
  • 5 years of site management experience
  • In-depth knowledge of regulatory requirements
  • Proficiency in clinical trial software

Work Rights

Not specified

Tailored Resume

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