Principal Research Scientist

Há 22 horas


Recife PE, Brasil beBeeClinical Tempo inteiro

Job Summary We are seeking a detail-oriented and experienced Clinical Research Associate to monitor and manage clinical trials. The CRA will ensure the trial is conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. This position involves collaborating with investigators, site personnel, and cross-functional teams to ensure the safety and well-being of participants in early-phase clinical trials. 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. Required Skills and 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. Additional qualifications include: 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. ,


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