Study coordinating staff

1. Data entry and maintenance of the databases of the clinical studies carried out in the Unit. 2. Monitoring and compliance with clinical protocols, Good Clinical Practice standards and current legislation on clinical trials, observational studies and other associated biomedical research projects. 3. Completion of the data collection notebooks (CRD) of clinical studies. 4. Monitoring visits, audits and inspections. 5. Processing of biological samples, ensuring the preservation and shipment of samples to the assigned laboratory, when appropriate and according to the conditions required by the legislation concerning the handling of human samples. 6. Participate in the assessment of inclusion/exclusion of patients in active clinical studies. 7. Participate in the complementary assessments of the protocol with the investigator, sponsor, monitor or coordinator personnel. 8. Manage the Investigator’s Staff Manual and clinical files. 9. Resolution of clarifications. 10. Reporting of Serious Adverse Events, if applicable, to the health authority. 11. Archiving and control of the documentation of completed studies. 12. Attendance and active participation in the meetings of the investigator and/or study coordinator.