Hybrid Clinical Trial Associate TMF & Site File Support

IQVIA Inc; Washington (District of Columbia); Hybrid; USD 49,000 - 123,000; Full time

Job summary

IQVIA MedTech, part of IQVIA, is seeking a Clinical Trial Associate to support the In-House CRA and Clinical Trial Manager with essential documents, regulatory tracking, and start-up activities. This hybrid role is based in Washington, DC, with 2-3 days in the office.

You will maintain TMF, ISF binders, and trial supplies, assist with quality audits and CAPAs, and help build strong relationships with site staff and project teams.

Qualifications

• Bachelor's degree in a scientific, management or related discipline.
• 1-2 years of experience in an office environment.
• Proficiency with MS Office applications.
• Demonstrated professional oral and written communication.

Responsibilities

• 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 supporting periodic review of study files 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 (Corrective and Preventative Actions) 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.).

Skills

Communication skills

Education

Bachelor's degree in a scientific, management or related discipline

Tools

MS Office

Job description

IQVIA MedTech, part of IQVIA, is seeking a Clinical Trial Associate to support the In-House CRA and Clinical Trial Manager with essential documents, regulatory tracking, and start-up activities. This hybrid role is based in Washington, DC, with 2-3 days in the office.

You will maintain TMF, ISF binders, and trial supplies, assist with quality audits and CAPAs, and help build strong relationships with site staff and project teams.