Clinical Trials Assistant

IQVIA Argentina; Petaling Jaya; Hybrid; MYR 30,000 - 50,000; Full time

Job summary

A leading clinical research services provider, IQVIA Argentina, seeks a Clinical Research Assistant in Petaling Jaya. The role involves supporting CRAs, managing clinical documentation, and ensuring compliance with protocols. This opportunity is perfect for candidates with a relevant Bachelor's degree and keen organizational skills.

Qualifications

• 1-3 years of experience in a clinical research environment.
• Basic knowledge of GCP and ICH guidelines.
• Strong administrative experience for non-clinical candidates.

Responsibilities

• Assist in updating and maintaining clinical documents and systems.
• Support preparation, handling, and filing of clinical documentation.
• Track and manage Case Report Forms and clinical data flow.

Skills

Communication

Time Management

Organizational Skills

Education

Bachelors Degree in Pharmaceutical or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Responsibilities:

• 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.

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

Job Requirements:

• Bachelors Degree in Pharmaceuticalor related field

• Min. 1 - 3 years of experience in clinical research environment

• Open to candidates from non-clinical research environment but strong experience in administrative duties

• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Broad knowledge of applicable protocol requirements as provided in company training

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

• Good 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

#LI-Hybrid

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