Clinical Trial Assistant

IQVIA LLC; Kuala Lumpur; On-site; MYR 36,000 - 60,000; Full time

Job summary

IQVIA in Kuala Lumpur seeks a detail-oriented administrative support professional to assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams in maintaining the Trial Master File (TMF) and related documentation.

This role emphasizes accuracy, document handling, timely filing, and coordination across study teams to ensure regulatory compliance and project timelines, with potential on-site participation in monitoring activities after training.

Qualifications

• High School Diploma or equivalent with at least 3 years of administrative support experience.
• Equivalent combination of education, training and experience.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication in English.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships.
• Awareness of applicable clinical research regulatory requirements such as GCP and ICH.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF to track site compliance and performance.
• Prepare, handle, distribute, file and archive clinical documents and reports per SOPs.
• Conduct periodic review of study files for completeness.
• Assist with distribution of Clinical Trial Supplies and maintain tracking information.
• Track and manage Case Report Forms (CRFs), queries and clinical data flow.
• Serve as central contact for project communications and documentation.
• Attend on-site visits with CRAs to assist with monitoring duties after training.

Skills

Time management

Organizational skills

Written & Verbal communication

English proficiency

Relationship building

Adaptability

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Overview

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Assist with periodic review of study files for completeness.

Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.

Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

High School Diploma or equivalent 3 years administrative support experience.

Equivalent combination of education, training and experience.

Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.

Written and verbal communication skills including good command of English language.

Effective time management and organizational skills.

Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.

Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.