Senior Clinical Research Associate (Medical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Research Associate (Medical): Managing investigator site monitoring and close-out of clinical trials to ensure patient safety and quality execution with an accent on GCP compliance and site management. Focus on resolving protocol-related issues, conducting onsite monitoring, and ensuring the integrity of study data.
Location: Remote (South Korea). Significant travel (60-80%) within the area is required
Company
A global pharmaceutical leader dedicated to discovering, developing, and delivering breakthrough therapies and vaccines.
What you will do
- Perform investigator site management and monitoring from site initiation through to database lock.
- Act as the primary point of contact for investigator sites and facilitate communication between study teams and vendors.
- Conduct onsite and remote monitoring to ensure compliance with Study Monitoring Plans, SOPs, and GCP standards.
- Identify and resolve site issues, developing corrective and preventative actions (CAPA) to prevent recurrence.
- Oversee investigational product handling, including receipt, storage, and destruction activities.
- Mentor and train junior Clinical Research Associates and serve as an SME for CRA processes.
Requirements
- Bachelor's or professional degree in life sciences, nursing, pharmacy, or medical background.
- Minimum 3 years of relevant experience in clinical research site monitoring.
- Must be based in South Korea.
- Fluent in English (C1) and native Korean.
- Valid driver's license and passport for significant travel (60-80%).
- Extensive knowledge of ICH/GCP and local country regulations.
Nice to have
- Experience in Oncology (preferably 2+ years), Vaccines, Internal Medicine, or Infectious Diseases.
- Previous experience with global clinical trials.
Culture & Benefits
- Remote work assignment for the home base.
- Opportunity to work within a global matrix team environment.
- Professional development and mentorship opportunities.
- Inclusive culture as an equal opportunity employer.
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