Intern Clinical Research Associate

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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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R253740