Senior Clinical Research Associate (Oncology Experience Required) – Paris Region, France (Remote) – FSP
About the role
About Parexel
At Parexel, we share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by a deep conviction in what we do. Each team member contributes to the development of a therapy that ultimately will benefit a patient.
Role Overview
We are seeking a Senior Clinical Research Associate with oncology experience to be based in the Paris region, France. Experience in oncology trials and RECIST criteria is essential. The Senior CRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on-site visit requirements.
Key Responsibilities
- Ensure regulatory, ICH-GCP and protocol compliance, using judgment and experience to evaluate overall performance of site and site staff
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject
- Demonstrate diligence in protecting the confidentiality of each subject and assess factors that might affect subject safety and clinical data integrity
- Conduct monitoring activities using different methods (both on-site and remote) as allowed by country regulations
- Conduct source document review and verification of appropriate site source documents and medical records
- Verify required clinical data entered in the Case Report Form (CRF) is accurate and complete
- Manage reporting of protocol deviations and appropriate follow-up
- Apply query resolution techniques remotely and on-site, providing guidance to site staff
- Perform Investigational Product (IP) inventory, reconciliation and review storage and security
- Collaborate with the Site Manager to assure the site complies with the protocol and is inspection ready
- Coordinate with institutions and investigators at the local level