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Senior/Clinical Research Associate

1 hour, 27 minutes ago
South Korea
Full-time
Junior
Project Manager
Project and Program Management
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 116

Description

  • Oversee study site management to protect patient safety and maintain high-quality data.
  • 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.
  • Assist with study budget negotiations and investigator contract execution when required.
  • Verify informed consent procedures and assess site issues affecting patient safety or data integrity.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits onsite and remotely.
  • Prepare accurate and timely monitoring reports, follow-up letters, trip reports, and communication logs.
  • Review ISF documentation, reconcile it with the TMF, and support essential document archiving requirements.
  • Perform IP inventory, reconciliation, storage, security, and labeling/release activities as needed.
  • Review EDC/CRF and patient data, resolve queries, and support data discrepancy resolution.
  • Identify and process serious adverse events and escalate site risks with recommended contingencies.

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 experience preferred.
  • High proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Working knowledge of the drug development process.
  • Fluency in English, both verbal and written.
  • Ability to travel 60-70% of the time.
  • Customer service demeanor with flexibility and teamwork.
  • Strong attention to detail and accuracy.
  • Experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.

Benefits

  • Competitive employment with a mission-focused organization working on groundbreaking cancer therapies.
  • Opportunity to work in a growing company where employee contributions are recognized.
  • Chance to share input and have ideas valued and nurtured.
  • Equal opportunity employer status with accommodations available for applicants with disabilities.
  • Privacy and applicant data protections are provided under the company privacy policy.

Interested in this position?

Apply directly on the company website

Apply Now

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