Senior Clinical Research Associate (Oncology Experience Required) – UK (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 is underpinned by a deep conviction in what we do. Each team member contributes to the development of therapies that benefit patients.
Role Overview
Senior Clinical Research Associate (Oncology Experience Required) for UK-based sponsor dedicated roles. This position requires experience in oncology trials and RECIST criteria. A minimum of 4 years' experience in CRO or Pharma trials environments 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 and documentation for each subject
- Protect subject confidentiality and assess factors affecting subject safety and clinical data integrity
- Conduct monitoring activities using different methods (on-site and remote) as allowed by country regulations
- Conduct source document review and verification of 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 and reconciliation as needed
- Collaborate with the Site Manager to ensure compliance and inspection readiness
- Coordinate with institutions and investigators at the local level
Requirements
- Minimum 4 years' experience in CRO or Pharma trials environments
- Experience in oncology trials
- Knowledge of RECIST criteria
- Familiarity with ICH-GCP Guidelines and applicable regulations
- Knowledge of company Standard Operating Procedures (SOPs) and processes