Study Quality Assurance Specialist

5 days ago


kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time
Job Description

The Clinical Research Associate will be responsible for ensuring that study sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

This role involves performing site monitoring visits, working with sites to adapt subject recruitment plans, administering protocol training, and evaluating the quality of study site practices.

You will also be responsible for managing the progress of assigned studies by tracking regulatory submissions, recruitment and enrollment, case report form completion, and data query generation and resolution.

Main Accountabilities
  • Ensure sites are conducting the study and reporting data as required.
  • Perform site monitoring visits and work with sites to adapt subject recruitment plans.
  • Administer protocol training and establish regular lines of communication.
  • Evaluate the quality of study site practices and escalate quality issues as necessary.
  • Manage the progress of assigned studies.
Essential Skills and Qualifications
  • Bachelor's Degree in a scientific discipline or healthcare preferred.
  • At least 1 year of on-site monitoring experience.
  • Good knowledge of clinical research regulatory requirements and therapeutic knowledge.
  • Excellent communication and organizational skills.
  • Ability to establish and maintain effective working relationships.

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