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Clinical Research Associate

2 mesi fa

Milano, Lombardia, Italia IQVIA Argentina A tempo pieno

Job Overview

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

Key Responsibilities

  1. Site Management and Monitoring
  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  1. Training and Communication
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  1. Quality and Compliance
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  1. Study Progress Management
  • 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. May support start-up phase.
  1. Documentation and Record-Keeping
  • 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 GCP and local regulatory requirements.
  1. Reporting and Communication
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  1. Collaboration and Support
  • Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

  1. Education and Experience
  • Bachelor's Degree in scientific discipline or health care preferred.
  • Requires at least 1 year of on-site monitoring experience.
  1. Skills and Knowledge
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., 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 use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Written and verbal communication skills including good command of 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.