IQVIA is a leading global provider of contract research services, advanced analytics and technology solutions to the life sciences industry, formed through the merger of IMS Health and Quintiles.

For our Croatian team we are currently looking for a CRA - Clinical Research Associate to join our local monitoring unit and support local health care practitioners in further advancing human science, together.

CRA Job And Function Overview

Monitor during clinical research studies to ensure trials are being conducted in accordance with widely accepted clinical practices. Conduct on-site and remote monitoring; develops tools, procedures and processes to ensure quality monitoring. Perform monitoring and site management work to ensure that sites are conducting the studies and reporting study data as required by the protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• 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
• 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
• Written and verbal communication skills including good command of English language and Croatian language

#CRAFSAJD

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.