Clinical Trial Admin & Documentation Specialist

NCBioImpact; Durham (NC); On-site; USD 36,000 - 123,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services, regulatory consulting and data analytics. This on-site role supports the RSU team by updating trial master files, preparing documents, and maintaining study files to ensure site compliance within project timelines.

The position requires a Bachelor’s degree and at least three years of administrative support experience, with strong MS Word/Excel/PowerPoint skills, clear English communication, and reliable time management.

Qualifications

• Bachelor's degree required.
• At least 3 years of administrative support experience.
• Equivalent combination of education, training and experience.
• Working knowledge of Microsoft Word, Excel and PowerPoint.
• Strong written and verbal English communication.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships.
• GCP and ICH regulatory awareness as per company training.

Responsibilities

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and TMF.
• Assist the clinical team with preparation, handling, distribution, filing, and archiving of documents and reports.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation and distribution of Clinical Trial Supplies and tracking information.
• Assist with tracking and management of Case Report Forms (CRFs) and data flow.
• Act as central contact for the clinical team for project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring duties after training.

Skills

Communication skills

Time management

Relationship building

GCP/ICH awareness

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA is a leading global provider of clinical research services, regulatory consulting and data analytics. This on-site role supports the RSU team by updating trial master files, preparing documents, and maintaining study files to ensure site compliance within project timelines.

The position requires a Bachelor’s degree and at least three years of administrative support experience, with strong MS Word/Excel/PowerPoint skills, clear English communication, and reliable time management.