Hybrid Clinical Trial Associate — TMF & Site Support

IQVIA; Washington (District of Columbia); Híbrido; USD 49 000 - 123 000; Tempo integral

Resumo da oferta

The Clinical Trial Associate (CTA) at IQVIA MedTech supports the In-House Clinical Research Associate and Clinical Trial Manager to ensure optimal management of essential documents with logistical and administrative tasks related to clinical trial start-up, execution and closing.

This hybrid role requires 2–3 days in the Washington, DC office and focuses on essential document management, regulatory file tracking and quality initiatives.

Qualificações

• Proficiency with MS Office applications.
• Demonstrated professional oral and written communication.

Responsabilidades

• Support clinical project team by updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Maintain Trial Master File (TMF) for multiple studies, including periodic review for accuracy and completeness.
• File, track and archive TMF documentation and reports.
• Create Investigator Site File (ISF) binders and patient binders for site use.
• Handle, distribute and track clinical trial supplies (non-IP) for site use.
• Support in-house CRA in documentation of all training sessions and/or meeting minutes as needed.
• Assist Clinical Affairs and Clinical Quality Assurance teams with preparation for internal quality audits and tracking of internal CAPAs as part of quality management reviews.
• Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.)

Conhecimentos

MS Office proficiency

Oral & written communication

Formação académica

Bachelor's degree in science/management

Descrição da oferta de emprego

The Clinical Trial Associate (CTA) at IQVIA MedTech supports the In-House Clinical Research Associate and Clinical Trial Manager to ensure optimal management of essential documents with logistical and administrative tasks related to clinical trial start-up, execution and closing.

This hybrid role requires 2–3 days in the Washington, DC office and focuses on essential document management, regulatory file tracking and quality initiatives.