
Clinical Trial Intern
4 days ago
**The Opportunity**
This Intern position reports to the Clinical Operations Manager and interfaces with the Site Management and Regulatory & Site Activation Team. The trainee will be involved in the process of managing clinical trials for novel therapies at the country level.
**Assignment Scope & Learning Opportunities**:
(Under the guidance)
- Support of Clinical Research Associates in managing clinical trials
- Update Clinical Trial Management Systems and Trial Master Files
- Data mining and investigator outreach for feasibility studies
- Support the submission of regulatory and ethics submissions of clinical trials
- Clinical Trial Assistant Onboarding Plan (includes: IQVIA in the Clinical Research Industry, Ethics in Clinical Research, Fundamentals of Good Clinical Practice Training & Exam, Regulatory Inspection Readiness, Clinical Trial Management System Training, Introduction to electronic Trial Master File)
- Understanding Site Activation (Includes: The process of starting up a clinical trial in Malaysia, Finding the right investigators for a clinical trial in Malaysia, Regulatory Documents Collection, Review, Approval and Maintenance)
- Perform tasks assigned by a manager in either the site activation or site management department.
**Skills & Experience Required**
- Tertiary degree in relevant areas e.g. healthcare, biosciences, pharmacy, etc
- Good interpersonal communication and organizational skills
- Good written and verbal communication skills including good command of English
- Good attention to detail
- General awareness clinical trial environment and drug development process
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
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