Judit Baranyi

Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures. Performed all tasks relevant to study participant, including screening and educating subjects, caregivers, and referral sources on protocol specific details and expectations. Expertly conducted full range of patient and protocol assessments, including safety and efficacy. Coordinated and monitored clinical trial activities to support timely and accurate completion of studies. Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning. Active contributor in investigator/sponsor and coordinator meetings, sharing valuable study data and insight as requested. Increased study engagement both with patients and site staff along with support study compliance requirements to meet sponsor goals. Maintenance of study regulator documents, including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs. Completion of case report forms (CRF/eCRF), answer the queries. Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials. Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.