Experience in Clinical Research, focusing in Clinical Coordination, since 2012: 50 projects, including phase II, III e IV of Osteoporosis, Hypertension, Diabetes (type I and II), Osteoarthritis, Rheumatoid Arthritis, Asthma, Rhinitis, Influenza / Cold, Lupus, Heart Disease, Low back pain Studies. Excellent Knowledge of GCP / ICH, National Legislations Coordination and supervision of 8 assistants; Completing and queries resolution of paper and electronic Case Report Form (CRF) – Platforms: Oracle, Medidata RAVE, Inform, Genexion, Medscale; Ample experience in IVRS and IWRS; Supervision and management of Clinical Trial ensuring all study procedures are being executed according to the protocol and Good Clinical Practice; First contact between sponsor/CRO and site to clarify issues related to clinical trial;  Responsible for resolution of outstanding issues during the monitoring visit, issues on Follow up Letter and answering Data Clarification Form; Training site staff in the protocols and the Protocol Amendments; Participation in meetings, initiation visit and close out visit; Participation and responsible by monitoring, auditing and qualifying visit; Elaboration of Subject Retention Plan and Recruitment; Elaboration and submission of serious adverse event, protocol’s deviation to Ethics Committee and Sponsor/CRO;  Responsible for Investigator File organization (Archiving of Curriculum, Training, Certificate, Newsletter, Monitoring Confirmation Letter, Follow up letter, Correspondences and updating delegation); Responsible for controlling of the equipment calibration; Responsible for elaboration of Standard Operating Procedure (SOPs); Ensuring that images of studies are being transmitted within; Experience in performing training in Good Clinical Practice; Implementation of weekly reports to the principal investigator with updates of each study;

The same as described in Clinical Research Auxiliary position field.

 Completing paper and electronic Case Report Form (CRF): Plataforms: Oracle, Medidata RAVE, Inform, Genexion and resolution of queires Knowledge in IVRS and IWRS: screening subjects, randomization, dispensing investigational product, characterization of screen failure, discontinuation or end of study or end of treatment, add new shipment of study medication and others;  Participation in monitoring visits, meetings, initiation and close out visit; Elaboration of serious adverse event, protocol´s deviations, safety reports (CIOMS) and submit them to Ethics Committee and the sponsor / CRO; Control of receipt, storage, dispensing and inventory of study medication and temperature logs; Accounting Investigational Product and verify the subject´s adherence and filling study medication log; Shipping X Ray and Densitometry to SYNARC and management of supplies (airway bill, envelope, labels, transmission form).

Assistance in clinical trials conduction to assess the efficacy and safety of study drug in type II diabetic subjects who have high cardiovascular risk or renal failure disease. My main tasks were completition of paper or eletronic CRF ( Plataforms: Oracle, INFORM and RAVE), dispense study drug by IWRS (Clinphone), study drug reconciliation, report serious adverse event to sponsor by FAX and/or eCRF, prepare documents and submit them to Adjudication team, report temperature excursion, update medication log of the protocols, practice pharmaceutical care to the participant. In the Regulatory Affairs I was responsible to develop safety report (CIOMS), semiannual reports, deviations forms, and serious adverse event and elaborate their submission letter and send them to the Ethics Committee in Research.