Clinical Trial Assistant

IQVIA LLC; Hinoba-an; On-site; PHP 240,000 - 400,000; Full time

Job summary

IQVIA LLC is seeking an Administrative Support Professional to assist the clinical team with TMF delivery and document handling. You will support CRAs and RSU, ensure timely filing, and help maintain study files in accordance with SOPs.

The role requires strong English communication, reliable time management and proficiency in MS Word, Excel and PowerPoint. On-site responsibilities and collaboration with multiple teams are essential for success.

Qualifications

• High School Diploma or equivalent required.
• 3-4 years administrative support experience, preferably in clinical research.
• Basic knowledge of GCP and ICH guidelines from company training.
• Strong written and verbal English communication.
• Proficient in Microsoft Word, Excel and PowerPoint.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF and related documents.
• Prepare, handle, file and archive clinical documentation per SOPs.
• Review study files for completeness on a periodic basis.
• Coordinate distribution of Clinical Trial Supplies and track information.
• Serve as central contact for project communications and documentation.

Skills

Administrative support

English communication

Time management

Organization

Team collaboration

Microsoft Office proficiency

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 and 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.

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.