Intern - Clinical Research Associate
Job Description
This Intern position under the oversight of the line-manager will have interfaces with across the different specific roles within the Global Clinical Trial Operations of Malaysia-Singapore Team.
The Intern will be involved in the process of supporting administratively, the conduct of clinical trials for novel therapies at the country level.
Assignment Scope & Learning Opportunities:
(Under the guidance)
- Rotational Assignment for an overview and supporting the roles of Clinical Trial Coordinator, Clinical Operations Manager, and Clinical Research Associate.
- Perform tasks as assigned which may include but not limited to; document management, regulatory and site start-up, clinical drug shipments, ancillary supplies shipments, dashboards/metrics reporting analysis, meeting planning, and other tasks as appropriate.
- Overview into Clinical Trial Systems:
- Clinical Trial Management System - SPECTRUM
- electronic Trial Master Files (eTMF) and supporting administratively with document management where appropriate
- Dashboards and Reporting
- Other systems as appropriate
- Support the submission of regulatory and ethics submissions of clinical trials. - Understanding Site Ready:
- Coordinates & manages various tasks in collaboration with other roles to achieve Site Ready. Includes: The process of starting up a clinical trial across Malaysia-Singapore, Regulatory Documents Collection, Review, Approval and Maintenance
Competency Expectations:
Tertiary degree in relevant areas e.g. healthcare, biosciences, pharmacy, etc
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- General awareness of clinical trial environment and drug development process
- Good word processing skills and knowledge of MS Office applications
- Good attention to detail
- The intern will be trained online and well as on- the -job to appreciate the role of: Clinical Research Associate and Clinical Trial Coordinator.
Behavioural Competency Expectations:
- Effective time management, organizational and interpersonal skills, conflict management
- Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
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Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/29/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:11/29/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R306209