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CRA I

JR065549

About the role

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As a Clinical Research Associate I at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - III, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

  • At least 12 months experience as an independent monitor
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 60%) domestic and/or international.
  • Familiarity with ICON's SOPs/WPs, ICH-GCP and appropriate regulations
  • Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
  • Familiarity with principles of investigator recruitment.
  • Assist with coordinating all the necessary activities required to set up and monitor a study, including the following identifying investigators.
  • Help, when requested, in preparation of regulatory submissions. Design patient information sheets and consent forms.
  • Coordinate documents translation, verification and back translations where required.
  • Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
  • Pre-study/placement and initiation visits.
  • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP as appropriate.
  • Maintain all files and documentation pertaining to studies.
  • Motivate investigators in order to achieve recruitment targets.
  • Complete accurate study status reports.
    Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
  • Keep the Project Manager regularly informed.
  • Process case record forms to the required quality standards and timelines .
  • Deal with sponsor generated queries in a timely manner.
  • Ensure the satisfactory close-out of investigator sites.
  • Ensure correct archiving of files on completion of a study.
  • Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits.
  • Participate in feasibility studies for new proposals, as required
  • Maintain patient and sponsor confidentiality .
  • lnvestigational Products (IPs) stored and managed by the site
  • Ensure storage conditions and acceptable supplies are provided
  • Ensure IPs are supplied only to eligible patients Ensure IP receipt, use and return are controlled and documented
  • Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
  • To participate, if requested, in the preparation of and review of study documentation e.g., draft protocols, draft CRFs, monitoring guidelines and elements of final report.
  • Participate in data listing reviews, as applicable.
  • Assist with marketing the company if and when appropriate.
List #1

Day in the life

Two medics at ICON clinical research clinic
The Strategic Role of Site Selection and Activation in Clinical Trials

Teaser label

Industry

Content type

Blogs

Publish date

10/28/2025

Summary

Precision at the Outset: The Strategic Role of Site Selection and Activation in Clinical Trials The success of any clinical trial begins well before the first patient is enrolled. Behind every sit

Teaser label

Explore the critical role of site selection and activation in clinical trials.

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A Career Focused on Patients: Daniela's Journey at ICON

Teaser label

Our People

Content type

Blogs

Publish date

10/27/2025

Summary

Daniela’s Journey at ICON Daniela Gutierrez’s career at ICON has been a journey of transition, determination, and purpose. What began as a role in study start-up has evolved into a position deeply

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Daniela shares insights into how collaboration, purpose, and innovation drive every part of her work.

Read more
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ICON Careers Spotlight: Chris Maguire, Director of Finance Business Partnering

Teaser label

Our People

Content type

Blogs

Publish date

10/15/2025

Summary

Chris Maguire’s Journey at ICON Over the past eight years at ICON, Chris Maguire has held six roles within the finance function, each expanding his expertise and sharpening his ability to support

Teaser label

Discover how Chris Maguire’s collaborative approach has shaped a rewarding career journey at ICON.

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