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Clinical Research Associate
2 months ago
The Site Monitor I will be responsible for ensuring data integrity, data quality, and compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. This role will involve monitoring activities in line with the Study Monitoring Plan (SMP) and collaborating with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.
Key Responsibilities:- Ensure regulatory, ICH-GCP, and protocol compliance by evaluating overall site performance and providing recommendations for site-specific actions.
- Verify the process of obtaining informed consent and assess factors that might affect subject safety and clinical data integrity.
- Conduct source document review and verification of site source documents and medical records.
- Manage reporting of protocol deviations and follow up on issues.
- Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
- Collaborate with the Site Manager and other stakeholders to ensure site-level activities are managed effectively.
- A minimum of 1 year experience as a clinical monitor/clinical research associate with demonstrated experience of on-site monitoring.
- Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence).
- Proficiency in local language is required, and English proficiency is also required.
Parexel is a leading global biopharmaceutical services company that provides a range of services to support the development and delivery of innovative therapies. As a Site Monitor I, you will have the opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of patients.
