Senior Clinical Research Associate

hace 2 semanas


Ciudad de México, Ciudad de México IQVIA A tiempo completo
Job Overview

As a Senior Clinical Research Associate at IQVIA, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site monitoring visits to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations, and sponsor requirements.

Key Responsibilities

  • Conduct site monitoring visits to assess the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality 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 that 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 GCP and local regulatory requirements.
  • Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
  • Collaborate with study team members for project execution support as appropriate.

Requirements

  • Bachelor's Degree in a scientific discipline or healthcare preferred.
  • At least 3.6 years of on-site monitoring experience.
  • Good knowledge of and skill in applying applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Good therapeutic and protocol knowledge as provided in company training.
  • Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
  • Written and verbal communication skills, including a 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.


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