Opportunity Expired
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.
Following the trainee program, the successful trainee will be able to apply for roles as a Clinical Trial Assistant/Clinical Research Associate or Start-up Specialist in a CRO or Pharma/Biotech company.
(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.
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 word processing skills and knowledge of MS Office applications
Good attention to detail
General awareness of the clinical trial environment and drug development process
Ability to establish and maintain effective working relationships with co-workers, managers, and sponsors
The opportunity is available to applicants in any of the following categories.
Malaysia
Malaysian Temporary Work Visa
Malaysian Citizen
Malaysian Permanent Resident