Clinical Trial Support Specialist

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

Job summary

IQVIA is a leading global provider of clinical research services and healthcare insights. A hands-on administrative support role supports CRAs and the RSU team by updating TMF, handling and filing clinical documents, and ensuring site compliance within project timelines.

The position involves preparing, distributing and archiving study materials, reviewing study files for completeness, and coordinating the flow of CRFs and data. Training in GCP and ICH guidelines is provided.

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 RSU team with updating and maintaining clinical documents and TMF to track site compliance and performance within project timelines.
• Assist the clinical team with preparation, handling, distribution, filing, and archiving of clinical documentation and reports per scope of work and 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 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 and documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties after required training.

Skills

Communication

Time management

Organizational skills

English language proficiency

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA is a leading global provider of clinical research services and healthcare insights. A hands-on administrative support role supports CRAs and the RSU team by updating TMF, handling and filing clinical documents, and ensuring site compliance within project timelines.

The position involves preparing, distributing and archiving study materials, reviewing study files for completeness, and coordinating the flow of CRFs and data. Training in GCP and ICH guidelines is provided.