Senior Remote Site Monitor on several phases I, II and III, multicentre, randomized, double-blind clinical trials Perform all aspects of in-house site management in accordance with good clinical practices and conducted regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilities. Co-monitoring in all types of on-site Monitoring Visits: PSV, SIV, IMV and COV. Use of different clinical and/or client specific system for trial management, such as eDiaries, Preclarus Dashboard and Safety Report portal. Familiar with AIM methodology and Risk Based Monitoring. Implement strategies to boost subject recruitment and enrolment. Responsible for budget and payments activities Responsible for Vendor Management at site level.Document all phase of issues management (from root cause analysis to follow up ad resolution)Escalate to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines. Served as the primary study contact for sites, responds to ad-hoc site requests for assistance and assists sites with the resolution of outstanding data queries. Provide ongoing site training, ensures study systems are updated per agreed study conventions to ensure adequate communication to project team and sponsor. Act as an active coordinating role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines. Perform data review using ECD, IWRS, central lab data, ePRO, imaging and other available online portals, as well as in-house local CTMS system for reporting. Involved in local final and interim analysis.Provide training to new hires, Junior and Senior colleagues as Subject Matter Expert

Provide administrative and technical support to Project Teams. Coordination responsibilities of project administration as applicable to client contracts under direction. Managed procedures and guidelines from different sponsors and/or monitoring environments. Responsibilities included but were not limited to: performing file reviews at any level, mass mailing and communication to sites, processing regulatory and other study specific documents, entering quality data, reviewing and updating document metrics and findings, submitting documents to the files, updating and maintaining vendor trackers and maintaining data repositories. From Jan 2014 to May 2015 conducted a pilot study as In House CRA on phase III, multicentre, randomized, double-blind placebo controlled, Prostate Cancer, in adult subjects. Managed and supported clinical monitoring activities remotely. Collaborated with CRAs in the resolution of detected site issues and pending actions. Supported drug and supply management activities. Ensured completeness and quality of site-specific data. Updated relevant tracking systems. Reviewed patient recruitment and site payment status. Followed-up on data entry, query and SAEs status. Ensured compliance with relevant guidelines, local requirements, SOPs and study specific procedures. Collected and compiled regulatory documents in collaborations with the CRA. Performed outbound and inbound calls on a regular basis to review recruitment plan, resolve issues pending from qualification visits, address protocol questions, check on site staff assignment and site facility status, request outstanding documents and to follow up on Clinical Site Agreement status and appropriate site related questions.

Provide administrative support for all study-related activities on national and international phases II, III and IV clinical studies. Prepared and maintained local study documentation relating to site initiation packages (SIP) requirements, amendments and ICF. Reconciled study documents. Supported the activity of CRAs on site from SIV to COV. Coordinated local data entry into study management system. Tracker study related documents. Managed logistic and document exchange between Hospital and Sponsor. Collected and distributed study supplies to site. Ordered processed and tracked Case Report Form.

Clinical Study Coordinator in more than thirthy clinical trials, phases I, II, III, biological, observational in Haematology/Oncology according to Good Clinical Practice. Support writing of no-profit clinical protocols. Preparation and submission of application to Local Ethic Committee and Local Regulatory Authorities. Management of clinical trials from qualification visit to termination visit. Supported local audit and inspections. Managed accountability of study drug. Supported creation of Case Report Form. Created and managed Access Database. Supported query resolution. Collaborated in Data analysis and creation of scientific abstracts.

Management of clinical trials documentation according to GCP. Data Collection in non-Hodgkin’s Lymphoma clinical data base.

Perform basic research in cellular culture, molecular biology, biochemistry techniques and renal pathophysiology