Florence, Tuscany, Italy
* Biomedical and clinical researcher * Good Clinical Practice * Good Laboratory Practice * 2018-Present: Oncology Clinical research, CRF forms, Bioethic permits, Protocols, TMF, ICF, ISF and SOPs * More than 8 years of Cellular laboratory experience in a wide range of established and advanced techniques * 4 years experience in clinical operations (between Study Coordinator in University and Company Role) * Interested in an international environment and a continue brainstorming * Interested in cutting-edge technology that can be applied to disease treatment * Good communication, inter-personal and organizational skills * Outstanding team working spirit * Good presentation skills * Good teaching skills and people management skills * GOAL ORIENTED and time management enthusiast *great flexibility and adaptaion *Can do attitude is a MUST Salva
Global Oncology clinical trials: -Full Management of Clinical Phase I Pharmacology Studies related to Oncology drugs (ADME, DDI, Special Populations) and Back up Management of Multicenter Solid Tumor Studies Phase I, II (Small molecules, ADC) Main tasks -Leads the development and execution of clinical trials globally to deliver with quality, on time, and within milestones and budget. -Coordinate cross-functional, cross-cultural teams in the implementation, execution and closure of phase I, II. -Accountable to oversight the enrollment strategies and execution. -Assess, identify and monitor trial-level risks. -Oversight all relevant Third Party Organizations (TPOs) / Contract Research Organizations (CROs) -Work with study team for developing and reviewing study budget and documents (such as Study Protocols, Informed Consent, Case Report Forms, study tools). -Manage Trial Master File (TMF) (paper and electronic) to ensure the file is current, complete and inspection ready at all time. -Oversee the Quality Control review of the clinical trial database and TMF. -Assist with preparation and execution of investigator and affiliate training meetings (eg. SIV slides, CRA training slides) -Prepare and distribute weekly presentation reports, ad hoc reports, summaries, or analyses as required. - Ensures timely documentation of deviations. -Detect and resolve quality issues and serious breaches, escalating to functional leadership or consulting other functions. -Review and participate in finalizing and obtaining approval of final Clinical Study Reports.
Working in Compliance with: -ICH GCP R2 2018 -SOPs -EMA, FDA Guidelines -Regulation (EU) No 536/2014 of European Parliament and of the Council (repealing Directive 2001/20/EC) -European and Italian Directives -GDPR/Data Breach Main Tasks: -Assistance in the management, start up, monitoring and close out of the clinical trials (project management) -literature study and pptx slideshow preparation (Gantt Chart and scientific schemes) -Database research (ESMO, ASCO, NCCN, NICE, Md Anderson etc.) and Database Competitive Portal Analsysis (Cortellis, Globaldata) -TMF, eTMF (Phlexglobal), IB, Protocol, Amendaments, eCRF (Medidata), IMPD, ICFs, IWRS, Lab Manual, CTM manual, Medical Monitoring Plan Manual etc -co-operation with different company roles (physicians, pre-clinical, regulatory affairs ,business development, law) -collaboration with CROs and Vendors (monitoring, overview, Budget revision) -co-Monitoring Visits and Outcome report writing -Department Protocol Review Forum Coordination and Management -KPI,KRI,KQI development in clinical operations and CROs database Development -Laboratory Vendors Management and Sample Management
*developing new prototypes and formulations (Food Supplements) *in vitro and ex vivo experiments *scouting raw materials *GLP *Collaboration management with Universities (Pre-clinical) *Poster presentation at conferences
Center for Systemic Manifestations of Hepatitis Viruses (MaSVE) Department of Experimental and Clinical Medicine University of Florence Largo Brambilla, 3 50134 - Firenze -ITALY Principal Investigator: Anna Linda Zignego *Clinical and Experimental Research on HCV related limphoproliferative deseases, special focus on the Onocology field *writing grant projects and scientific papers *collaboration with the Medical Staff and the clinical study coordinators to write clinical observational studies *databases and sample menagement
*Consultation of online medical records *Clinical Database Updates *Writing participation in the protocol and the documentation related to the clinical study (Informed consent, Letter to the doctor, diaries, Questionnaires) in collaboration with the clinical staff *Realization of Case Report Forms(CRF) (paper) *Communication Updates with the coordinators of other studies of the Adverse Events (AE), Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR). *Interaction with Clinical Research Associate (CRA) and Clinical Research Organization (CRO) *Managing of blood samples centralization and quality control (QC) of the diagnostic slides coloration *scientific writing *Preparing Lessons and talks for seminars
Main Tasks: *writing manuscripts, ethical permits for animal utilization, clinical observational studies *teaching students *design of experiment (DoE) and autonomous work on an assigned project *laboratory routine cleaning of instruments and software updates *conducting experiments in vivo, ex vivo and in vitro In the main project, we were analyzing the importance of the β-receptors in melanoma progression and aggressiveness. In particular, we are focusing our attention on the role of β3-receptor in the tumour immuno-tolerance and metabolism. Technical Skills and competences: In vivo mice studies, intra-peritoneal injection, intra-tumour injection; Ficoll isolation from buffy coat; homogenization of tumour tissue and spleen; separation of various lymphocytes population through autoMacs separator; Western blotting; RT-PCR; FACS analysis, etc. Additional Task: Organize the expeditions and the coloring of diagnosis glasses deriving from the Onco-ematology unit.