Study Coordinator

hace 7 días


Barcelona, España Vhir A tiempo completo

.The Nephrology and Kidney Transplantation Research Group is part of the University Hospital Vall d'Hebron (VHUH) located in Barcelona, a tertiary referral public center for Catalunya and many other areas of Spain.The HUVH is integrated by WomenChildren, General, and Trauma-Orthopedics Teaching Hospitals providing multidisciplinary care involving all pediatric and adult medical and surgical sub-specialties. We also work closely with the Pediatric Urology Service, which is accredited as a national reference service for complex urologic surgeries in children and adolescents. Furthermore, we are part of the Renal Physiopathology Group at the Vall d'Hebron Research Institute (VHIR).Our research is focused on Inherited Tubulopathies (Dent disease, Familial hypomagnesemia with hypercalciuria nephrocalcinosis), and rare kidney diseases. In the clinical research field, we are fully committed to the development of new therapies in pediatric patients and thus, we participate in several international clinical trials and academic research projects focused on chronic kidney disease in children and rare kidney diseases.Education and Qualifications: Required: Bachelor's Degree in Pharmacy and Master in Clinical Trials. Additional training in Paediatric Clinical Trials and assessment of biomedical research projects by Clinical Research Ethics Committee (CEIm). Fluency in Catalan, Spanish, and English (business level).Desired: Studying for a PhD. Training in Good Clinical Practice (GCP) - ICH E2 (R6).Experience and Knowledge: Required: At least 4 years of experience working in clinical trials. At least 4 years of experience working in pediatric hospital environments. Computer literacy (Office package, mail, eCRF).Desired: Highly organized and methodical, with strong motivation and initiative. Excellent communication skills. Ability to respond quickly to requests from the team and sponsor.Main Responsibilities and Duties: Information to potential participants in clinical trials.Conduct and supervise the tasks related to clinical trials and research projects.Coordinate with different vendors: Sample and medication couriers, digital patient platforms (questionnaires, diaries...), IVRS, payment platforms, home nurses, medical imaging platforms, sample and imaging central laboratories, trial management platforms.Report to Pharmacovigilance: notify and explain the SAEs and follow up on them.Application to Clinical Research Ethics Committee (CEIm) for research projects.Selection, inclusion, and follow-up of patients in clinical trials.Handling biological samples: centrifugation, freezing, shipping to central laboratories, etc.Maintain up-to-date clinical data from source documents in eCRFs, CTMS, and ISF.Coordination of clinical trials to ensure compliance with the protocol.Attend site-monitoring visits, review and resolve queries in accordance with GCP.Labour Conditions: Full-time position: 40h/week. Starting date: Immediate



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