CTA

IQVIA•Washington, DC

12h•Hybrid

About The Position

MCRA is part of IQVIA MedTech, a trusted CRO and advisory partner that delivers integrated lifecycle solutions for the medical device and diagnostics industry. Together, they support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. The Clinical Trial Associate (CTA) 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. The CTA supports regulatory document collection and tracking of monitoring visits and enrollment at the study-level. Responsible for completion of administrative tasks relating to implementing quality initiatives and the quality management system as applicable.

Requirements

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.)