Clinical Monitoring Associate; Reading

Role Overview: A Clinical Research Associate supporting Oncology studies will oversee site management activities across the UK to ensure compliance with GCP and ICH guidelines.

• Conduct site monitoring visits, including selection, initiation, monitoring, and close-out, ensuring adherence to protocol and regulations.
• Collaborate with sites to develop and track subject recruitment plans, enhancing study predictability.
• Provide protocol and study training to site staff, maintaining effective communication to manage project expectations and issues.
• Assess and maintain the quality and integrity of site practices, escalating issues as needed.
• Track study progress, including regulatory submissions, recruitment, CRF completion, and data queries, supporting study start-up activities.
• Ensure proper documentation filing in the Trial Master File and Investigator's Site File, verifying compliance with regulatory standards.
• Generate monitoring reports, follow-up letters, and maintain comprehensive site management records.
• Coordinate with study team members to support project execution.

• Experience in independent on-site monitoring for Oncology studies, particularly unblinded trials.
• Strong knowledge of GCP and ICH guidelines.
• Life science degree or equivalent industry experience.
• Willingness to travel to study sites as required.