Clinical Research Associate II

1 week ago

Atlanta, Georgia, United States PRA Health Sciences Full time

About the Role

We are seeking a highly skilled Clinical Research Associate II to join our team at PRA Health Sciences. As a Clinical Research Associate II, you will be responsible for conducting clinical trial site visits, including evaluation, initiation, monitoring, and close-out.

Key Responsibilities

  • Conduct clinical trial site visits to ensure compliance with regulatory requirements and study protocols.
  • Oversee and report on the conduct of clinical trials at a site level, including online site visit reports and updates to electronic management systems.
  • Proactively manage site relationships, including building and maintaining professional relationships with site staff.
  • Facilitate subject enrollment, incorporating recruitment strategies and action plans at site level.
  • Maintain site audit/inspection readiness and ensure appropriate safety reporting.
  • Verify electronic case report form data against written and electronic source documentation.
  • Respond to site queries and escalate issues in accordance with processes and timelines.
  • Conduct IP accountability and reconciliation, and facilitate implementation of new technologies and systems at clinical sites.
  • Maintain site study supplies.

Requirements

  • Bachelor's degree in a scientific discipline or nursing equivalent.
  • At least 2 years of on-site monitoring experience in phase II and phase III trials.
  • Working knowledge of Electronic Data Capture (EDC) systems.
  • Experience in the oncology disease area is preferred.
  • 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 home office.
  • Competent computer skills, including working knowledge of common software packages.
  • Working knowledge of trial management databases and online systems.

About PRA Health Sciences

PRA Health Sciences is a global healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence. As a Clinical Research Associate II, you will be part of a team that is shaping the future of clinical development.

What We Offer

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A diverse and inclusive work environment.
  • Recognition and rewards for high performance.

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