Intern, Clinical Trials null

JOB DESCRIPTION

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.

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 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