Clinical Trial Assistant

IQVIA LLC; Pasig; On-site; PHP 250,000 - 380,000; Full time

Job summary

IQVIA is seeking a detail-oriented Administrative Support professional to join our Clinical Research Operations in Metro Manila. You will assist CRAs and RSU teams with TMF documentation and ensure timely, accurate file delivery.

You will handle preparation, filing, and archiving of clinical documents, track CRFs, and coordinate communications across the project, with some on-site site visits after training.

Qualifications

• High School Diploma or equivalent.
• 3-4 years administrative support experience.
• Minimum one year clinical research experience strongly preferred.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Strong written and verbal English communication skills.
• Good time management and organizational abilities.
• Ability to interact effectively with coworkers, managers and clients.
• Basic knowledge of GCP/ICH guidelines as provided in training.

Responsibilities

• Assist CRAs and RSU team with updating and maintaining TMF documents and systems.
• Prepare, handle, distribute, file and archive clinical documents and reports per SOPs.
• Review study files for completeness.
• Coordinate tracking and management of CRFs, queries and data flow.
• Serve as central contact for project communications and documentation.
• May accompany CRAs on site visits for monitoring duties after training.
• Collaborate with clinical team on document preparation and archiving.

Skills

Administrative support

Time management

Communication

English language

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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. Coordinate 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.

Qualifications

High School Diploma or equivalent. 3-4 years administrative support experience. Equivalent combination of education, training and experience. Minimum one year clinical research experience strongly preferred. 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. Basic knowledge of applicable clinical research regulatory requirement, 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.

Company

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.