Hello, Welcome!I'm a detail-oriented professional with ICH-GCP certification and extensive experience in clinical research across various therapeutic areas, including oncology, ophthalmology, and rare diseases. Proven ability to enhance operational efficiency and ensure compliance through effective communication and training initiatives. Proficient in conducting site visits, ensuring protocol compliance, and maintaining audit readinessSignificant expertise in facilitating the introduction of innovative testing methods, such as the SARS-CoV-2 antibody test, which advanced immunization efforts. Strong analytical skills demonstrated through scientific research leading to published findings, while consistently adhering to Good Laboratory Practices.Skilled in executing Source Data Reviews (SDR) and Source Data Verification (SDV), ensuring accurate documentation within Clinical Trial Management Systems (CTMS) to uphold audit readiness and comply with ICH-GCP guidelines. Experienced in developing and implementing training programs for laboratory techniques and equipment, resulting in increased user proficiency and operational effectiveness.My key strengths include being skilled in critical thinking, problem-solving, communication skills (both oral and written), customer service, effective interpersonal skills, analytical skills, organization, attention to detail and result oriented. Proficient in Microsoft Office (advanced Excel), Ms. Teams, SharePoint, Trello, and Concur. Intermediate in Agile tools (Kanban board, Scrum), and Salesforce. Fluent in English and Portuguese as a native speaker. Expertise in Clinical trial management systems, medical terminology and therapeutic areas, Regulatory Compliance, in vitro diagnostic – Hb1Ac, performing experimental model treatment and surgery, pre-clinical research, Molecular biology (PCR, RT-PCR, Digital PCR), Good laboratory practice (GLP), National Glycohemoglobin Standardization Program Validation, Western blot, Protein Electrophoresis (SDS-PAGE), High-Performance Liquid Chromatography (HPLC), eTMF, ISIF, EDC and adept at learning new software applications and In-depth knowledge of ICH-GCP guidelines and applicable regulations, such as FDA, EMA and ANVISA.📧 luhnevess@gmail.com