Hugo Duarte Email & Phone Number

São Paulo, São Paulo, Brasil

• I am the first contact point between the site and the sponsor being responsible for communication effectively with study team, clinical trial manager (CTM), vendor, sponsor and other stakeholders, assisting subject recruitment and retention planning, activation and initiation site.• Execution activites of clinical research projects: site iniciation, feasibility, pre-trial assessment, budget analysis, start up,regulatory affairs, recruitment pacients, conduct studies and site study close out• Organization of clinical trial documents, study files, Investigator File and Trial Master File • Management and conduct studies phases I, II, III, IV in accordance with Good Clinical Practices (GCP), FDA guidelines, Standard Operating Procedures (SOP), work intrusctions and local regulation.• Verifying and/or correcting research study information on source documents; researching queries and variances; conduct patient interviews, answer questions, follow up on issues. • Provind support to the Project Team Study and start up activities: CDA, negotiation, distribution and collection documents, Site File preparation and site activation.• Accurate input of trial data into the Electronic Data Capture (EDC) and resolve data queries ensuring accuracy, validity and completeness of data collected.• Engage with the clinical team in verifying subject eligibility (inclusion and exclusion criteria), facilitating subject enrollments and contribuite to recruitment strategy.• Discute with Principal Investigator about clinical aspects and reports: adverse events(AE) and serious adverse events (SAEs) ensuring adequate informations.• Regulatory Affairs activities : IEC/IRB submissions and notifications as required within Brazil and regulatory documents organization• Management clinical study suplies: laboratory kits, equipaments and others. • Participate scheduled team meetings ,trainings and monitoring visits.

São Paulo, São Paulo, Brasil

• Conduct oncology studies phases I, II, III, IV and regulatory compliance in accordance with Good Clinical Practices, FDA guidelines, SOPs and local regulation. • Verifying and/or correcting research study information on documents; researching queries and variances; providing feedback to the site data collector.• Accurate input of trial data into the Electronic Data Capture (EDC) system • Act as point of contact for study participants by inform them of study objectives, answering questions, administering questionnaires, schedule visits and ensuring study compliance.• Discute with Principal Investigator about clinical aspects and reports: adverse events(AE) and serious adverse events (SAEs) ensuring adequate informations.• Communicate effectively with study team, leadership, vendor, sponsor and other team members• Participate in investigator and team meetings, monitoring visits, close out visits.

Belo Horizonte, Minas Gerais, Brasil

• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• Provide administrative support for site management activities to Clinical Project Manager and leads • Maintain clinical project documents in paper and/or electronic Trial Master Files and perform TMF reconciliation and period review follow-Up ensuring all documents archived • Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project managemen• Prepare clinical study documentation ( Study Files, CRF Files, Monitoring Files.)

Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brasil

Belo Horizonte, Minas Gerais

Itabira, Minas Gerais, Brasil

Itabira, Minas Gerais

Professor da disciplina Estágio Supervisionado e Ensino Clínico

Itabira, Minas Gerais, Brasil

Academic Master'S Degree In Applied Cancer Sciences, Health Sciences, 90

Graduate Lato Sensu-, Specialization In Oncology Nursing

Graduate Lato Sensu- Specialization, Cardiology And Hemodynamics

Bachelor'S Degree, Nursing, 92%