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Clinical Research Associate

1 hour, 39 minutes ago
China
Full-time
Junior
Operations Specialist
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 101

Description

  • Oversee study site management to protect patient safety and ensure high-quality data with low query levels.
  • Provide guidance on audit readiness and support audit preparation and follow-up actions.
  • Update, track, and maintain study management tools, systems, and status reports.
  • Manage site start-up activities, including feasibility, investigator recruitment, EC/IRB submissions, and regulatory document review when required.
  • Support study budget negotiation and investigator contract execution when required.
  • Verify informed consent documentation and assess site-level risks such as protocol deviations and pharmacovigilance issues.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits, and prepare timely monitoring reports.
  • Document site activities, maintain communication logs, and support recruitment, retention, and awareness strategies.
  • Review Investigator Site Files, reconcile them with the Trial Master File, and ensure essential documents are archived properly.
  • Communicate protocol and study issues to site personnel and project teams, escalating risks and driving timely resolution.

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 applications, 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% of the time.
  • Customer-service mindset with flexibility and teamwork.
  • Strong attention to detail and accuracy over extended periods.
  • Solid experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.
  • Good knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.

Interested in this position?

Apply directly on the company website

Apply Now

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