Senior Clinical Research Associate
New
P
Precision Medicine GroupLife Sciences, Oncology
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 equivalent combination of education and experience.
- Minimum 2 years of on-site monitoring experience.
- 1 year of oncology experience preferred.
- Fluency in English (verbal and written).
- High proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Working knowledge of the drug development process.
- Solid knowledge of ICH-GCP, SOPs, and regulatory guidance.
- Ability to travel 60-70%.
Responsibilities
- Oversee all aspects of study site management to ensure patient safety and data quality.
- Conduct site visits including pre-study, initiation, routine monitoring, and close-out.
- Manage site start-up procedures, including feasibility, recruitment, and regulatory documentation.
- Maintain study-specific trial management systems and status reports.
- Perform investigational product inventory, reconciliation, and security reviews.
- Review EDC CRF and patient profiles to assist in data quality and query resolution.
- Identify and escalate site risks and process Serious Adverse Events.
- Document monitoring activities through trip reports and communication logs.
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