Senior Oncology Clinical Research Coordinator

Há 5 horas

Brasil beBeeClinicalResearchAssociate Tempo inteiro

Job Overview We are seeking a highly skilled and detail-oriented Clinical Research Associate to join our team. The ideal candidate will have experience in conducting Phase 2 clinical trials, with a strong understanding of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines. The CRA will be responsible for monitoring and managing clinical trials, ensuring compliance with regulatory standards, and collaborating with investigators, site personnel, and cross-functional teams. Key Responsibilities Site Management and Monitoring: Conduct site qualification, initiation, interim monitoring, and close-out visits. Ensure proper site adherence to protocols, GCP, and regulatory requirements. Verify and ensure accurate data collection and reporting. Assess site performance and provide corrective actions if necessary. Regulatory Compliance: Ensure all clinical trial documentation is maintained according to regulatory guidelines. Review informed consent documents and confirm proper consenting procedures. Collaborate with regulatory teams to ensure timely submissions and approvals. Safety and Data Management: Monitor and report adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities. Validate source data and resolve data discrepancies. Ensure timely and accurate documentation of clinical trial data in electronic data capture (EDC) systems. Collaboration and Communication: Build and maintain relationships with study investigators and site staff. Communicate study updates and findings to study sponsors and internal teams. Provide training to site personnel on study protocols, procedures, and GCP compliance. Qualifications Bachelor's degree in Life Sciences, Nursing, or a related field. At least 2-4 years of experience as a Clinical Research Associate in oncology trials, with preference for Phase 2 experience. Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent organizational, problem-solving, and communication skills. Preferred Qualifications Previous experience in early-phase oncology trials (e.g., dose escalation studies, first-in-human trials). Strong understanding of pharmacokinetics (PK) and pharmacodynamics (PD) assessments. Certification as a Clinical Research Professional (CCRA) is a plus.

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