Clinical Trial Associate — TMF & Start-Up Support

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

Job summary

IQVIA MedTech is seeking a Clinical Trial Associate to support the in-house Clinical Research team with essential documents and administrative tasks across trial start-up, execution and closing. This hybrid role is based in Washington, DC and involves regulatory document collection and TMF maintenance.

The CTA will assist with QA and CAPA tracking, system updates, and coordination with PIs, study coordinators, and QA teams to ensure quality, compliance and timely study milestones.

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

• Update and maintain clinical systems tracking site compliance and performance within project timelines.
• Maintain Trial Master File (TMF) for multiple studies; support periodic reviews for accuracy.
• File, track and archive TMF documentation and reports.
• Create Investigator Site File (ISF) binders and patient binders for site use.
• Handle, distribute and track non-IP clinical trial supplies for site use.
• Support in-house CRA with documentation of training sessions/meeting minutes.
• Assist Clinical Affairs and QA teams with preparation for internal quality audits and CAPAs.
• Develop and maintain positive relationships with clients, team members and site personnel.

Skills

Oral written communication

Office experience

Education

Bachelor’s degree in a scientific/management related discipline

Tools

MS Office

Job description

IQVIA MedTech is seeking a Clinical Trial Associate to support the in-house Clinical Research team with essential documents and administrative tasks across trial start-up, execution and closing. This hybrid role is based in Washington, DC and involves regulatory document collection and TMF maintenance.

The CTA will assist with QA and CAPA tracking, system updates, and coordination with PIs, study coordinators, and QA teams to ensure quality, compliance and timely study milestones.