Junior Clinical Research Associate Sponsor dedicated📣 إعلان

About the Junior Clinical Research Associate Role

IQVIA is seeking a Junior Clinical Research Associate to join its team in Riyadh, Saudi Arabia. This is a full-time position dedicated to supporting sponsor requirements within clinical research studies.

Role Overview

The Junior Clinical Research Associate performs essential monitoring and site management activities. The primary objective is to ensure that study sites conduct clinical trials and report data in strict adherence to the study protocol, applicable regulations, guidelines, and sponsor requirements.

Key Responsibilities

• Conduct site monitoring visits, including selection, initiation, monitoring, and close-out, in accordance with the contracted scope of work and regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Collaborate with sites to adapt, drive, and track subject recruitment plans to align with project needs and enhance predictability.
• Administer protocol and related study training to assigned sites and establish clear communication channels to manage ongoing project expectations and address issues.
• Evaluate the quality and integrity of study site practices concerning protocol adherence and compliance with applicable regulations, escalating quality issues as necessary.
• Manage study progress by tracking regulatory submissions and approvals, recruitment and enrollment figures, Case Report Form (CRF) completion and submission, and data query generation and resolution. May provide support during the study start-up phase.
• Ensure that required copies or originals of site documents are available for filing in the Trial Master File (TMF) and verify the proper maintenance of the Investigator's Site File (ISF) in line with GCP and local regulatory requirements.
• Create and maintain comprehensive documentation related to site management, monitoring visit findings, and action plans through regular visit reports, follow-up letters, and other necessary study documentation.
• Liaise and collaborate with study team members to provide project execution support as appropriate.
• Support the development of project subject recruitment plans on a per-site basis, if applicable.
• Manage site financial aspects according to the executed clinical trial agreement and retrieve invoices as per local requirements, if applicable.

Qualifications and Experience

• Requires at least a few months to one year of on-site monitoring experience.
• An equivalent combination of education, training, and experience may be considered in lieu of a formal degree.

Work Environment and Location

This is a full-time position based in Riyadh, Saudi Arabia, supporting clinical research operations within the region.

Application Information

Candidates meeting the specified requirements are encouraged to apply.