Experienced Clinical Research Associate - Multi Sponsored
Role Overview
Perform clinical study monitoring and site management to ensure studies are conducted and reported according to protocol, regulations, guidelines, and sponsor requirements.
Key Skills for This Role
Full Job Posting
Job overview
Perform clinical study monitoring and site management to ensure studies are conducted and reported according to protocol, regulations, guidelines, and sponsor requirements.
Monitoring and site management
- Conduct site selection, initiation, monitoring, and close-out visits in line with contracted scope and applicable requirements.
- Work with sites to adapt and track subject recruitment plans.
- Provide protocol and study training to assigned sites and maintain communication about project expectations and issues.
- Evaluate study-site practice quality and integrity, verify compliance, and escalate quality issues.
- Track regulatory submissions and approvals, recruitment, enrollment, case report forms, and data queries.
- Support study start-up when applicable.
- Ensure site documents are filed in the Trial Master File and Investigator Site Files are maintained to GCP and local requirements.
- Prepare monitoring records, visit reports, follow-up letters, findings, and action plans.
- Collaborate with study teams to support project execution.
- Support recruitment planning and site financial management, including invoice retrieval, when applicable.
Qualifications
- At least one year of on-site monitoring experience is required.
- A bachelor's degree in a scientific or healthcare discipline is preferred; equivalent education, training, and experience may substitute.
- Knowledge of applicable clinical research requirements, including GCP and ICH guidelines.
- Therapeutic and protocol knowledge as provided in company training.
- Computer skills including Microsoft Word, Excel, and PowerPoint, plus laptop and applicable mobile-device use.
- Written and verbal communication skills, Arabic fluency, and a good command of English.
- Organizational, problem-solving, time-management, and financial-management skills.
- Ability to build and maintain effective working relationships with coworkers, managers, and clients.
About IQVIA
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for life sciences and healthcare.
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