Clinical Trials Assistant (12 months contract)

SGP IQVIA RDS East Asia Pte Ltd.; Singapore; Hybrid; SGD 40,000 - 60,000; Full time

Job summary

A leading global clinical research provider is seeking a Clinical Research Assistant to support the clinical team in maintaining clinical documents and ensuring compliance. The ideal candidate will hold a Bachelor's Degree in a related field, possess strong organizational and administrative skills, and have a basic understanding of clinical research regulations. This role offers a hybrid working environment in Singapore.

Qualifications

• Min. 1 - 3 years of experience in clinical research environment.
• Basic knowledge of clinical research regulatory requirements.
• Effective time management and organizational skills.

Responsibilities

• Assist CRAs and RSU team with updating clinical documents.
• Prepare, distribute, file, and archive clinical documentation.
• Track and manage Case Report Forms and clinical data flow.

Skills

Communication skills

Time management

Organizational skills

Computer skills

Education

Bachelors Degree in Pharmaceutical or related field

Tools

Microsoft Word

Excel

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

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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