Hybrid Clinical Trial Admin & Documentation Specialist

IQVIA; Wilmington (DE); On-site; USD 36,000 - 123,000; Full time

Job summary

IQVIA is seeking an Administrative Support professional to assist Clinical Research Associates and the RSU team in maintaining the Trial Master File and related systems. Your work will help ensure site compliance and timely project delivery by accurately updating documents and coordinating with the clinical team.

You will handle preparation, distribution, filing, and archiving of essential clinical documentation, support review of study files for completeness, and act as a central contact for

Qualifications

• Bachelor's degree or equivalent combination of education, training and experience.
• 3 years administrative support experience.
• Working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills with good command of English.
• 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 (GCP and ICH) and protocol knowledge.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF and related systems to track site compliance and timelines.
• Assist with preparation, handling, distribution, filing and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist with handling Clinical Trial Supplies and maintenance of tracking information.
• Track and manage Case Report Forms (CRFs), queries and data flow.
• Act as a central contact for project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring duties after training.

Skills

English communication

Time management

Organizational skills

Interpersonal skills

Regulatory awareness

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA is seeking an Administrative Support professional to assist Clinical Research Associates and the RSU team in maintaining the Trial Master File and related systems. Your work will help ensure site compliance and timely project delivery by accurately updating documents and coordinating with the clinical team.

You will handle preparation, distribution, filing, and archiving of essential clinical documentation, support review of study files for completeness, and act as a central contact for