Clinical Trial Support Specialist

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

Job summary

IQVIA, a global leader in clinical research services, seeks an administrator to support CRA/RSU teams by maintaining trial master files and documentation. You will help prepare, file, archive, and review study files, and aid in the distribution of trial materials and data tracking.

The role involves liaison with cross-functional teams and may include site visits after training. Strong communication, organization, and MS Office proficiency are essential, along with familiarity with GCP/ICH

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., GCP and ICH guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF and related documents.
• Assist with preparation, handling, filing, and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist with handling and distribution of Clinical Trial Supplies and tracking information.
• Assist with tracking and management of CRFs, queries and clinical data flow.
• Act as central contact for designated project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring after training.

Skills

Microsoft Word

Microsoft Excel

PowerPoint

Written and verbal communication

Time management

Organizational skills

Team collaboration

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA, a global leader in clinical research services, seeks an administrator to support CRA/RSU teams by maintaining trial master files and documentation. You will help prepare, file, archive, and review study files, and aid in the distribution of trial materials and data tracking.

The role involves liaison with cross-functional teams and may include site visits after training. Strong communication, organization, and MS Office proficiency are essential, along with familiarity with GCP/ICH