Clinical Trial Admin & Documentation Specialist

Regulatory Toolkit; Overland Park (KS); On-site; USD 36,000 - 123,000; Full time

Job summary

IQVIA is a global leader in clinical research services and health information services. IQVIA seeks an administrative support professional to assist the CS and RSU teams with maintaining TMF documents, handling clinical reports, and coordinating study materials to ensure timely on-site and off-site project progress.

The role emphasizes accuracy, regulatory awareness (GCP/ICH), strong English communication, and the ability to collaborate across cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor's DegreeRequired
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• 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.
• 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

Attention to detail

Communication skills

Team collaboration

Education

Bachelor's Degree

Tools

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is a global leader in clinical research services and health information services. IQVIA seeks an administrative support professional to assist the CS and RSU teams with maintaining TMF documents, handling clinical reports, and coordinating study materials to ensure timely on-site and off-site project progress.

The role emphasizes accuracy, regulatory awareness (GCP/ICH), strong English communication, and the ability to collaborate across cross-functional teams in a fast-paced environment.