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 international Real World Evidence team we are currently looking to engage with a Clinical Research Associate (II) to take care of late phase studies, both remotely and on-site, within Czech Republic.

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. Escalate quality issues as appropriate.
• 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 Degree in scientific discipline ideally
• Ideally a minimum of 1 year's experience of independent monitoring
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Written and verbal communication skills including good command of Czech and English language.
• Effective time management, problem-solving and communication skills.
• Valid driving license

Why should you apply?

• You'd join a global team of 70.000+ brave minds
• In 2020 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

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.