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Clinical Research Associate
Location: Manchester, England, United Kingdom Contract Type: Full Time
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A clinical oncology study-focused role across the UK.
## About the Role
The Clinical Research Associate (CRA) will play a critical role in supporting oncology clinical trials, spanning multiple sites across the UK.
## Responsibilities
- Perform site monitoring visits (selection, initiation, on-site monitoring, and close-out) following the contracted scope and adherence to GCP (Good Clinical Practice)
- Collaborate with sites to adapt, drive, and track subject recruitment plans, ensuring predictability based on project needs
- Administer protocol-related training to assigned sites, establishing clear lines of communication to manage ongoing expectations and resolve issues
- Evaluate and ensure the quality and integrity of study site practices, identifying compliance with protocols and regulatory requirements before escalating any quality concerns
- Track and manage assigned studies by monitoring:
- Regulatory submissions and approvals
- Recruitment and enrollment progress
- CRF (Case Report Form) completion and submission
- Generation and resolution of data queries (may contribute to study start-up phases where applicable)
- Ensure accuracy and completeness of trials-related documentation, including:
- Copies/originals (as required) for the Trial Master File (TMF)
- Maintenance of the Investigator’s Site File (ISF) per GCP and local regulations
- Generate study-related documentation, such as:
- Regular visit reports
- Follow-up letters
- Action plans
- Liaise with the study team as needed to support project execution
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## Requirements
- Proven experience in independent, on-site monitoring of oncology therapeutic area studies (unblinded trials)
- In-depth knowledge of Good Clinical Practice (GCP) and ICH (International Conference on Harmonization) guidelines
- Degree in a life science discipline (or equivalent industry experience)
- Ability to travel to sites as required to conduct monitoring visits
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