CFSP Senior CRA 3, Hungary, Sponsor Dedicated

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 local Clinical FSP monitoring team we are currently looking to hire a Senior Clinical Research Associate III / SCRA III to join a team composed of 15 monitors dedicated to one major biopharmaceutical client.

The monitor will have an expected average DOS of 4 to 5 per month as we work on a risk based monitoring model, preserving the safety and work-life balance of our employees.

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) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP 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 or health care preferred
• Requires at least 5 years of independent on-site monitoring experience
• Deep knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command ofEnglishlanguage andHungarianlanguage.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

#CRASDAJD #LI-NM

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.