Overview
Support regulatory submissions and site start-up activities for clinical trials in South Korea, including site activation, essential documents, ethics and competent authority interactions, and contract support.
What you'll do
- Prepare clinical trial applications and submission dossiers for competent authorities and ethics committees.
- Manage responses and communications with competent authorities and ethics committees.
- Coordinate essential document collection, review, translation, and filing.
- Track site activation readiness, timelines, risks, and project deliverables.
- Customize patient information sheets and informed consent forms.
- Support site budget negotiations and investigator contract execution.
- Maintain knowledge of local clinical trial regulations and audit readiness.
What you'll need
- Bachelor's degree in life sciences or a related field, or Registered Nurse qualification, or equivalent education, training, and experience.
- At least 1 year of regulatory or site start-up experience in a CRO, pharmaceutical, or biotechnology setting.
- Strong communication skills.
- Strong organizational skills.
- Experience with computerized information systems, spreadsheets, word processing, and email.
- Fluency in English and Korean.
Nice to have
- Regulatory and site start-up experience specific to South Korea.
- Experience with milestone tracking tools or systems.
- Advanced medical or life sciences degree, RAC certification, or a Master's in Regulatory Science.
Details
- Work mode: Remote.
- Location: South Korea.
Read the full description and apply on the company’s own careers page.
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