Clinical Trial Associate Job at MCRA, an IQVIA business, Washington DC

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  • MCRA, an IQVIA business
  • Washington DC

Job Description

MCRA, an IQVIA business is seeking a strong In-House CRA to join our Clinical team. The In-House Clinical Research Associate will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm’s clientele.

Position Overview

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. This position is hybrid (2-3 days in office) out of our Washington, DC office.

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.)

Required 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

Job Tags

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