Sr. CRA, Sponsor Aligned, Oncology

Job description

Job Overview: Join our dynamic team as a Clinical Research Associate! You’ll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact on patients’ lives. Key Responsibilities: Site Monitoring Visits: Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines. Subject Recruitment: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met. Training & Communication: Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues. Quality Assurance: Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed. Study Progress Management: Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution. Support start-up phases as required. Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations. Reporting: Generate...