Senior Clinical Research Associate
New
P
Precision for MedicineClinical Research
Remote, South KoreaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum of 2 years of on-site monitoring experience
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree or international equivalent in a business, scientific or healthcare discipline.
- Minimum 2 years of on-site monitoring experience.
- Fluency in English (verbal and written).
- Proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
- Strong working knowledge of drug development process.
- Good knowledge of ICH-GCP, SOPs, and regulatory guidance.
- Ability to travel (60-70%).
- Oncology experience (1 year preferred).
- Strong organizational and interpersonal skills.
Responsibilities
- Oversee study site management to ensure patient safety and data quality.
- Conduct all forms of site visits including pre-study, initiation, routine monitoring, and close-out.
- Manage site start-up procedures and regulatory document collection.
- Perform investigational product (IP) inventory and reconciliation.
- Process Serious Adverse Events according to study procedures.
- Maintain study trial management tools and status reports.
- Communicate effectively with site personnel and project management.
- Assist in negotiation of study budgets and investigator contracts if required.
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