Clinical Research Associate

3 weeks ago

Miami, Florida, United States Pharmaceutical Research Associates, Inc. Full time

Overview

Pharmaceutical Research Associates, Inc. is a leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a Clinical Research Associate II for late phase trials.

Responsibilities

  • Conduct clinical trial site visits, including evaluation, initiation, monitoring, and close-out.
  • Oversee and report on the conduct of clinical trials at a site level, including online site visit reports and updates to electronic management systems.
  • Proactive site management, including building and maintaining solid and professional relationships with site staff, facilitating subject enrollment, and ensuring appropriate safety reporting.
  • Verify electronic case report form data against written and electronic source documentation as per study schema/monitoring plan.
  • Respond to site queries and escalate issues in accordance with processes and timelines.
  • Conduct IP accountability and reconciliation.
  • Facilitate implementation of new technologies and systems at clinical sites.
  • Maintain site study supplies.

Qualifications

  • BA/BS/BSc in the sciences or nursing equivalent.
  • A trained CRA with at least 2 years of on-site monitoring experience in phase II and phase III trials.
  • Working knowledge of Electronic Data Capture.
  • Experience/working knowledge of the oncology disease area.
  • Experience of Centralized/Risk Based/Targeted monitoring.
  • Experience of working within a metric-based environment.
  • Comprehensive knowledge and understanding of ICH-GCP.
  • Fluent oral and written English language skills.
  • Able and willing to travel up to 60% of the time.
  • Possession of a full driver's license.
  • Able and willing to work from a designated and appropriate home office.
  • Willing to attend and contribute to team meetings.
  • Competent computer skills.
  • Working knowledge of trial management databases and online systems.
  • Able to attend a 1-week face-to-face in-house training course.
  • Able and willing to work on several protocols/therapy areas.

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of benefits, including various annual leave entitlements, health insurance, retirement planning, and a global employee assistance program.

We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.

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