Experienced Clinical Research Associate Sponsor-dedicated📣 Job Ad

About the Role

IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence. This role is for an Experienced Clinical Research Associate, Sponsor-dedicated, based in Riyadh, Saudi Arabia. The position focuses on ensuring clinical trial sites adhere to study protocols, regulations, and sponsor requirements to maintain data quality and integrity.

Key Responsibilities

• Perform site monitoring visits, including selection, initiation, routine monitoring, and close-out, in accordance with the scope of work and Good Clinical Practice (GCP) standards.
• Collaborate with clinical trial sites to develop, implement, and track subject recruitment plans, adapting strategies to meet project timelines.
• Administer protocol and study training to sites, and establish regular communication to manage expectations and address issues.
• Evaluate site practices for quality and adherence to protocol and regulations, escalating concerns as needed.
• Manage study progress by tracking regulatory submissions, subject recruitment, CRF completion, and data queries. Support may be provided during study start-up.
• Ensure required site documents are available for the Trial Master File (TMF) and verify the Investigator's Site File (ISF) is maintained in compliance with GCP and local requirements.
• Create and maintain documentation for site management, including monitoring visit findings and action plans, through visit reports and follow-up letters.
• Liaise with other study team members to provide and receive support for project execution.
• Contribute to the development of project-specific subject recruitment plans on a per-site basis, where applicable.
• Manage site financial aspects in accordance with clinical trial agreements and retrieve invoices as per local requirements, if applicable.

Qualifications and Requirements

• A High School Diploma or equivalent degree in a scientific discipline or healthcare field is preferred.
• A minimum of 2 years of on-site clinical trial monitoring experience is required.
• An equivalent combination of education, training, and experience may be considered.
• Strong understanding and proficiency in applying clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic area knowledge and protocol understanding, as provided through company training.
• Proficiency in computer skills, including Microsoft Word, Excel, and PowerPoint, and experience using a laptop and mobile devices.
• Excellent written and verbal communication skills in both Arabic and English.
• Well-developed organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with colleagues, managers, and clients.

Required Skills

• Good Clinical Practice (GCP)
• ICH Guidelines
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Arabic Language Proficiency
• English Language Proficiency
• Organizational Skills
• Problem-Solving Skills
• Time Management Skills
• Financial Management Skills

Work Location and Type

This is a full-time position based in Riyadh, Saudi Arabia. IQVIA is committed to integrity in its hiring process and maintains a zero-tolerance policy for candidate fraud. All information submitted must be truthful and complete.