Therapeutic areas involved:- Oncology: Breast Cancer, Solid Tumours.- Metabolism: DM2 in pediatric population, Chronic Kidney Disease.

- Site qualification and selection (pre-study visits).- Clinical trial implementation, submission and site initiation visits.- Clinical trial conduction and monitoring visits (onsite and remote visits).- Clinical trial close-out visits.- Lead CRA functions: clinical trial budget revision; study site payments; liaison between site staffs and sponsor; development of study specific documents/forms; assemble and/or review regulatory essential documents and support in the Regulatory… Show more - Site qualification and selection (pre-study visits).- Clinical trial implementation, submission and site initiation visits.- Clinical trial conduction and monitoring visits (onsite and remote visits).- Clinical trial close-out visits.- Lead CRA functions: clinical trial budget revision; study site payments; liaison between site staffs and sponsor; development of study specific documents/forms; assemble and/or review regulatory essential documents and support in the Regulatory Authorities submissions and notifications; co-monitoring visits and onboarding of new CRAs; support in Audits and/or Inspections; local clinical trial overall management and tracking; planning and executing Investigators Meetings or other training sessions; establish and maintain collaborative team efforts both inter and intradepartmentally.Therapeutic areas involved:- Neurology: CVT and ESUS.- Metabolism: DM1/2 and Diabetic Nephropathy (phase 1 study); DM2 in pediatric population; Diabetic Retinopathy.- Respiratory: Asthma in pediatric population; COPD; IPF; fibrosing ILD in pediatric population.- Infecciology: Chronic Hepatitis C Virus.- Central Nervous System: Alzheimer Disease.- Gastroenterology: Ulcerative Colitis. Show less

Therapeutic Areas:- Cardiology: Acute Coronary Syndrome, Chronic Stable Angina Pectoris, Atrial Fibrillation, Chronic Heart Failure, Acute Coronary Syndrome, Arterial Hypertension, Atherosclerosis and Myocardial Infarction.- Endocrinology: Type 2 Diabetes.- Rheumatology: Rheumatoid Arthritis.- Oncology: Colorectal Cancer, Hepatocellular carcinoma, Non-Small Cell Lung Cancer, Breast Cancer.- Infectiology: Chronic Hepatitis C.Main responsibilities:- Assess clinical… Show more Therapeutic Areas:- Cardiology: Acute Coronary Syndrome, Chronic Stable Angina Pectoris, Atrial Fibrillation, Chronic Heart Failure, Acute Coronary Syndrome, Arterial Hypertension, Atherosclerosis and Myocardial Infarction.- Endocrinology: Type 2 Diabetes.- Rheumatology: Rheumatoid Arthritis.- Oncology: Colorectal Cancer, Hepatocellular carcinoma, Non-Small Cell Lung Cancer, Breast Cancer.- Infectiology: Chronic Hepatitis C.Main responsibilities:- Assess clinical study feasibility;- Verify and facilitate formal clinical study approval;- Prepare pre-selection/selection and initiation visits;- Plan the execution of clinical study;- Assist in subject recruitment;- Prepare study visits and coordinate study procedures;- Access to IVRS or IWRS;- Collect accurate and verifiable data and register all required data in CRF;- Maintain stocks of study and lab materials;- Process, store and send study samples to central lab;- Assure study drug compliance (drug accountability);- Prepare the documents related to subjects’ reimbursements;- Communicate with sponsor, monitor and with the other elements of the research team and, if applicable, with regulatory authorities;- Prepare monitoring visits and interact with monitors;- Coordinate study close out visits;- Safeguard the adherence to GCP principles, protocol and applicable laws and regulations;- Archive study documents and maintain study documents updated and organised - Investigator Site File, Pharmacy File and Subject´s' Files;- Prepare study site payments. Show less