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Clinical Research Associate

4 days, 11 hours ago
China
Full-time
Junior
Operations Specialist
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 148

Description

  • Oversee all aspects of study site management to protect patient safety and maintain data quality.
  • Serve as the primary point of contact for study sites and communicate study issues to project teams.
  • Conduct pre-study, qualification, initiation, routine monitoring, and close-out site visits.
  • Prepare and submit accurate, timely monitoring reports and other required study documentation.
  • Support site start-up activities, including feasibility, investigator recruitment, EC/IRB submissions, and regulatory document review.
  • Assist with study budget negotiations and investigator contract execution when required.
  • Review informed consent documentation, assess protocol deviations, and identify risks to subject safety and data integrity.
  • Perform investigational product inventory, reconciliation, storage, and accountability checks.
  • Review EDC/CRF data, resolve queries, and support correction of data discrepancies.
  • Track site status, action items, and trial management information in study systems and reports.

Requirements

  • Bachelor's degree or international equivalent, or an equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
  • Minimum of 2 years of on-site monitoring experience.
  • 1 year of oncology trial experience preferred.
  • High proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Fluency in English, both written and verbal.
  • Working knowledge of the drug development process.
  • Ability to travel 60-70%.
  • Customer-service demeanor with flexibility and teamwork.
  • Strong attention to detail and accuracy.
  • Solid experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.

Interested in this position?

Apply directly on the company website

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