Clinical Trial Associate: Documentation & Compliance

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

Job summary

IQVIA Inc. in Washington, DC is seeking a Clinical Trial Associate to support the In‑House CRA and Clinical Trial Manager with essential document management, TMF maintenance, and regulatory tracking across trials.

The role involves 2–3 days in the office, collaboration with QA and Clinical Affairs, and assistance with internal audits and CAPA tracking as part of the quality management system.

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 as part of quality management reviews.

Skills

MS Office proficiency

Professional communication

Education

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

Job description

IQVIA Inc. in Washington, DC is seeking a Clinical Trial Associate to support the In‑House CRA and Clinical Trial Manager with essential document management, TMF maintenance, and regulatory tracking across trials.

The role involves 2–3 days in the office, collaboration with QA and Clinical Affairs, and assistance with internal audits and CAPA tracking as part of the quality management system.