Clinical Trials Admin & Documentation Specialist

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

Job summary

IQVIA is seeking an Administrative Support Specialist to assist CRAs and the RSU team with document control and TMF upkeep to keep study timelines on track.

You will help prepare, file, and archive clinical documents, coordinate distribution, and maintain CRF tracking and data flow. Strong MS Office skills and knowledge of GCP/ICH are preferred; excellent communication and organization are essential.

Qualifications

• Bachelor's degree required.
• 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 (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 SOPs.
• 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

Communication skills

Time management

Relationship building

GCP/ICH awareness

Protocol knowledge

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA is seeking an Administrative Support Specialist to assist CRAs and the RSU team with document control and TMF upkeep to keep study timelines on track.

You will help prepare, file, and archive clinical documents, coordinate distribution, and maintain CRF tracking and data flow. Strong MS Office skills and knowledge of GCP/ICH are preferred; excellent communication and organization are essential.