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Clinical Research Associate II

1 hour, 55 minutes ago
China, Taiwan
Full-time
Junior
Project Manager
Project and Program Management
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 81

Description

  • Oversee study site management to protect patient safety and ensure high-quality data with low query rates.
  • Serve as the main point of contact for study sites and communicate study issues, deviations, and action plans to project teams.
  • Conduct site start-up activities, including feasibility, EC/IRB submissions, regulatory document review, and informed consent document support when required.
  • Assist with study budget negotiations and investigator contract execution when required.
  • Verify informed consent is properly obtained and documented and assess site-level risks to patient safety and data integrity.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits in accordance with protocol, local laws, ICH-GCP, and SOPs.
  • Prepare and submit accurate and timely monitoring reports, follow-up letters, trip reports, and other required study documentation.
  • Maintain trial management systems, status reports, tracking logs, and site records, including ISF/TMF reconciliation and archival readiness.
  • Support investigational product inventory, reconciliation, storage, dispensing, labeling, import, and return processes.
  • Perform data review activities, including EDC/CRF review, query resolution, SAE processing, and escalation of site risks.

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.
  • At least 1 year of oncology experience.
  • Global clinical trial experience.
  • High proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Fluency in English, both spoken and written.
  • Working knowledge of the drug development process.
  • Ability to travel 60-70% of the time.
  • Customer-service mindset with flexibility and teamwork.
  • Preferred: solid experience in clinical research or related experience.
  • Preferred: excellent organizational skills.
  • Preferred: ability to work efficiently in a remote work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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