Remote TMF & Clinical Trials Support Associate

Remote Jobs; United States; Remote; USD 34,000 - 45,000; Full time

Job summary

IQVIA in Reading, Berkshire, United Kingdom, is seeking a CTA 2–level Administrative Support professional to assist Clinical Research Associates and Regulatory and Start-Up teams. You will help update and maintain the Trial Master File, ensuring site compliance and project timelines.

You will prepare, handle, file and archive clinical documents and reports, participate in periodic study file reviews, and assist with study materials, CRFs and data flow.

Qualifications

• High School Diploma or equivalent.
• 3 years administrative support experience.
• Proficient in 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.

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.

Skills

Administrative support

Regulatory knowledge

Time management

Organizational skills

Written and verbal English

Communication skills

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA in Reading, Berkshire, United Kingdom, is seeking a CTA 2–level Administrative Support professional to assist Clinical Research Associates and Regulatory and Start-Up teams. You will help update and maintain the Trial Master File, ensuring site compliance and project timelines.

You will prepare, handle, file and archive clinical documents and reports, participate in periodic study file reviews, and assist with study materials, CRFs and data flow.