Clinical Research Associate with experience, Ireland

From research to real world, IQVIA weaves together the technologies, resources, and expertise our customers need to rise to the next opportunity. To look beyond what’s expected. To advance human health with newfound confidence.

For our Irish team we are currently looking to speak with experienced CRAs (Clinical Research Associates) to be based in Ireland to follow one major pharmaceutical company with sites spread across the island.

Essential Functions of a Clinical Research Associate (CRA)

• 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.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites 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 (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• 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.

Qualifications

• Bachelor's Degree or Master's Degree, ideally in scientific discipline or healthcare
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)

• Minimum of 12/18 months of independent monitoring experience
• Good therapeutic and protocol knowledge
• Written and verbal communication skills including good command of English language.

Why should you apply?

• You'd join a global team of 70.000+ brave minds

• In 2019 we completed almost 4.000 recruitment processes internally; once you join us, not even the sky is the limit

• We've been nominated a top 500 company every year since our inception in 2016

• FLEXJOBS awarded us the 9th spot in the top 100 Companies for Remote Jobs in 2021

The position is intended to be based remotely (home-based). We will offer a permanent contract and the chance to be part of a company that is redefining the meaning and scope of clinical trials around the world. Click here to see what FORBES had to say about us recently: https://www.forbes.com/sites/vijaygurbaxani/2020/11/29/cios-with-vaccines-on-the-horizon-its-time-to-accelerate/?sh=5ca3b83237a1

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.