Clinical Research Associate
il y a 4 semaines
Clinical Research Associate - Sponsor Dedicated
Job Overview
As a Clinical Research Associate - Sponsor Dedicated, you will be responsible for ensuring that sites are conducting studies and reporting data as required by the study protocol, applicable regulations, and sponsor requirements.
Key Responsibilities
Perform site monitoring visits to ensure compliance with contracted scope of work and regulatory requirements.
Work with sites to adapt and drive subject recruitment plans to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
Ensure accurate documentation of site management, monitoring visit findings, and action plans by submitting regular visit reports and generating follow-up letters and other required study documentation.
Collaborate with study team members for project execution support as needed.
Requirements
Bachelor's Degree in a scientific discipline or healthcare preferred.
At least 1 year of on-site monitoring experience required.
Good knowledge of clinical research regulatory requirements and therapeutic and protocol knowledge as provided in company training.
Excellent communication and organizational skills.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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