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3 semanas atrás

Belo Horizonte MG, Brasil beBeeClinical Tempo inteiro

Clinical Research Associate Job Description The role of a Clinical Research Associate (CRA) is to oversee the conduct of clinical trials. This involves collaborating with site personnel, investigators, and cross-functional teams to ensure compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. Key responsibilities include: 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 Requirements A candidate for this position should have: 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) Prioritization Skills A strong understanding of pharmacokinetics (PK) and pharmacodynamics (PD) assessments is desirable, as is certification as a Clinical Research Professional (CCRA). A proactive approach to problem-solving and excellent communication skills are essential for success in this role.

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