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Oncology Monitor Role
3 semanas atrás
We are seeking a highly skilled and experienced Clinical Research Associate (CRA) to join our team. This role offers the opportunity to work on clinical trials in oncology, utilizing your knowledge of Good Clinical Practice (GCP) and regulatory requirements.
In this position, you will be responsible for conducting site visits, ensuring compliance with study protocols, and maintaining consistent communication with site staff.
- Key Responsibilities:
- Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with contracted scope of work and GCP guidelines.
- Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
- Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
- Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
- Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
- Ensure essential documents are collected and maintained in both the Trial Master File (TMF) and Investigator Site File (ISF) in accordance with regulatory standards.
- Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
- Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
This is a field-based position requiring travel as required by the project.