Clinical Research Associate

6 hours ago

Copenhagen, Copenhagen, Denmark IQVIA Full time

Job Overview

We are seeking an experienced Clinical Research Associate to join our team in site management. As a CRA, you will be responsible for ensuring that sites are conducting studies and reporting data as required by the study protocol, regulations, and sponsor requirements.

Key Responsibilities:

  • Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with contracted scope of work and regulatory requirements.
  • 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 to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.

Requirements:

  • High School Diploma or equivalent degree in a scientific discipline or healthcare preferred.
  • Equivalent combination of education, training, and experience may be accepted in lieu of degree.
  • Basic knowledge of and skill in applying clinical research regulatory requirements, such as 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, and use of a laptop computer and iPhone and iPad (where applicable).

Salary Range: $60,000 - $90,000 per year, depending on experience.

About IQVIA: We are a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Our mission is to help our customers create a healthier world by pushing the boundaries of human science and data science.

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