Clinical Trial Assistant

IQVIA LLC; Kuala Lumpur; On-site; MYR 42,000 - 66,000; Full time

Job summary

IQVIA LLC in Kuala Lumpur is seeking a Clinical Trial Assistant to support daily administrative activities with CRAs and RSU teams. You will help maintain TMF documents, prepare and archive clinical reports, and assist with study file reviews to ensure timely, compliant delivery.

This role requires strong English communication, solid organizational skills, and knowledge of GCP/ICH guidelines. On-site in Kuala Lumpur, this position emphasizes collaboration with regulatory and start-up teams, with

Qualifications

• High School Diploma or equivalent.
• 3 years of administrative support experience.
• Working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal English communication skills.
• Effective time management and organizational skills.
• Ability to establish and maintain professional relationships with coworkers and clients.
• Awareness of GCP and ICH guidelines as provided in company training.

Responsibilities

• Perform daily administrative activities with CRAs and RSU teams.
• Maintain and update TMF documents and systems for site compliance.
• Prepare, handle, file, and archive clinical documentation and reports.
• Review study files for completeness on a periodic basis.
• Support distribution of Clinical Trial Supplies and tracking information.
• Track Case Report Forms, queries, and data flow.
• Serve as central contact for project communications and documentation.
• May accompany CRAs on site visits for monitoring duties after training.

Skills

Communication skills

Time management

Organizational skills

Written and verbal English

Relationship building

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

## Clinical Trial AssistantApplylocations: Wilayah Persekutuan Kuala Lumpur, Malaysiatime type: Full timeposted on: Posted Todayjob requisition id: R1560155**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