Clinical Research Associate

2 settimane fa

Milano, Lombardia, Italia IQVIA A tempo pieno
Job Overview

As a Clinical Research Associate at IQVIA, you will play a critical role in the success of our clinical trials. You will be responsible for conducting site monitoring visits, administering protocol and related study training, and evaluating the quality and integrity of study site practices.

Key Responsibilities
  • Complete therapeutic, protocol, and clinical research training to perform job duties
  • Gain experience in study procedures by working with experienced clinical staff
  • Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits
  • Administer protocol and related study training to assigned sites and establish regular lines of communication
  • Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements
Qualifications
  • Bachelor's Degree in a scientific discipline or healthcare preferred
  • Equivalent combination of education, training, and experience may be accepted in lieu of degree
  • Possession of the local ministerial decree as per Italian requirements
  • Prior clinical experience preferred
  • Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint
  • Written and verbal communication skills, including good command of the English language
  • Organizational and problem-solving skills
  • Effective time and financial management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
  • Advanced knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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