Clinical Trials Admin & Documentation Coordinator

IQVIA Inc; Columbus (OH); On-site; USD 36,000 - 123,000; Full time

Job summary

IQVIA is seeking an Administrative Support professional to assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams by updating and maintaining clinical documents and TMF, ensuring site compliance and timely project delivery.

The role includes handling and distributing clinical documentation, supporting study file reviews, tracking CRFs and data flow, and coordinating communications within the team.

Qualifications

• Bachelor's Degree required.
• 3 years administrative support experience.
• Equivalency of education, training and experience accepted.
• Proficient with Word, Excel and PowerPoint.
• Written and verbal communication in English.
• Strong time management and organizational skills.
• Ability to work with coworkers, managers and clients.
• Familiarity with GCP/ICH guidelines as provided in company training.
• Knowledge of protocol requirements as provided in training.

Responsibilities

• Assist CRAs and RSU team with updating and maintaining TMF and site documents.
• Assist with preparation, handling, distribution, filing and archiving of clinical docs.
• Review study files for completeness on a periodic basis.
• Support preparation and distribution of Clinical Trial Supplies and tracking information.
• Track and manage Case Report Forms, queries and data flow.
• Serve as central contact for project communications and documents.
• May accompany CRAs on site visits to assist with monitoring duties after training.

Skills

Administrative support

English communication

Time management

Organizational skills

Team collaboration

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA is seeking an Administrative Support professional to assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams by updating and maintaining clinical documents and TMF, ensuring site compliance and timely project delivery.

The role includes handling and distributing clinical documentation, supporting study file reviews, tracking CRFs and data flow, and coordinating communications within the team.