Clinical Research Associate, Argentina, IQVIA Biotech Specialist
hace 6 días
About the Role
Clinical Research Associates at IQVIA in Argentina are responsible for ensuring that sites conducting clinical studies are adhering to study protocols and applicable regulations. This role involves performing site monitoring visits to assess site practices and ensure compliance with Good Clinical Practice (GCP) guidelines.
Key Responsibilities
- Perform site monitoring visits to evaluate site practices and ensure compliance with GCP guidelines.
- Work with sites to adapt and track subject recruitment plans to enhance predictability.
- Administer protocol training to assigned sites and establish regular communication to manage ongoing project expectations and issues.
- Evaluate the quality of site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Manage study progress by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
- Liaise with study team members for project execution support as required.
Qualifications
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Requires at least 1 year of on-site monitoring experience.
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