Fernanda Lopes Email & Phone Number

São Paulo, São Paulo, Brasil

São Paulo, Brazil

Act as representative of Clinical Logistic Activities (drug supply management and vendor management) in the Study Team. Lead and execute logistic tasks and perform the oversight of outsourced centralized activities to ensure the right execution of the study. Responsible to manage the Clinical Logistic Support Manager activities.

São Paulo

Act as representative of Clinical Logistic Activities (drug supply management and vendor management) in the Study Team. Lead and execute logistic tasks and perform the oversight of outsourced centralized activities to ensure the right execution of the study. Responsible to manage the Clinical Logistic Support Manager activities.

São Paulo Area, Brazil

Set-up, conduct and closure of the Central Reading Activity (ECG/Imaging) managed by a CRO. Participating in the process from the beginning to the end, including: ckeck vendors availability, participation in bid defense meeting, CRO choice, regular meetings with involved actors (internal and external team), follow up of the activities, management of study closure activities, archive the sponsor study documents.

Knowledge of clinical methodology; GCP/ICH and local regulatory guidelines. Expirience as CRA in Clinical Trials Phases II and III in different therapeutic areas as Cardiovascular, Endocrine/Methabolic, Neurosciencies, iIncluding a big trial with more than 18.000 included patients worldwide of wich 1022 included patients in Brazil in 25 sites.Ensure running of clinical studies at the allocated sites according to technical Protocol, Good Clinical Practice, Local Regulations and company’s SOPs; Verifies that a research site is appropriately organized to conduct the clinical study; Performs site initiation visits, clinical monitoring visits, site close-out visits, as specified in the study-specific monitoring guide; Guarantee the IMP accountability during the study; regularly verify the storage, dispensation and retrievement of IMPs; Obtains and transmits to the sponsor all required documents from the clinical study site for the sponsor study file and/or as requested by the sponsor; Help the clinical study sites with study logistics, facilitates resolution logistical problems when required; Reporting safety information on the company products in accordance with regulatory requirements and standard operating procedure; Conducted feasibility process; Support Project Manager in local/regional study-related tasks.

Responsible CRA in Clinical Trials Phases III and IV; Budgets collaboration; Reviewed protocols, contracts, CRFs and informed consent; Regulatory documents setting; Prepared for and conducted site visits, including site qualification, study initiation and close-out visits.

Answer technical doubts to health care professionals (administration, dosage, conservation and others) ; Databases researching such Pubmed and other latin American Pharmacovigilance: notification of adverse events ocurred during the use of drugs; Clearing up technical doubts to the customers by email and phone (administration, dosage, security, drug interactions and others).