Clinical Research Associate
hace 2 meses
Job Overview
As a Clinical Research Associate at IQVIA, you will be responsible for ensuring the quality and integrity of study site practices related to the proper conduct of clinical trials. This includes performing site monitoring visits, adapting and driving subject recruitment plans, and managing ongoing project expectations and issues.
Key Responsibilities
- Perform site monitoring visits to evaluate the quality and integrity of study site practices.
- 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.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, and data query generation and resolution.
- Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP/ICH and local regulatory requirements.
Qualifications
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- Basic knowledge of and skill in applying applicable clinical research regulatory requirements.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.
- Written and verbal communication skills including good command of the English language.
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