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Transcript of CV GEMMA
CRA INVENTFARMA GROUP Laboratorios Lesvi SL NOV 2004 - JUNE 2005 CLINICAL RESEARCH ASSOCIATE INFOCIENCIA CLINICAL RESEARCH AUG 1999 - NOV 2004 AUXILIARY ADMINISTRATIVE INSTITUT CATALÀ DE LA SALUT National Healthcare Service PERIOD TITLE COMPANY PRESENTATION STRUCTURE EDUCATION WORK EXPERIENCE JOB DESCRIPTION AND ADQUIRED SKILLS TECHNICAL COURSES PERSONAL AND CONTACT INFORMATION AUG 1999 - NOV 2004 AUXILIARY ADMINISTRATIVE INSTITUT CATALÀ DE LA SALUT National Healthcare Service PERIOD TITLE COMPANY JULY 2008-MARCH 2012 CLINICAL TRIALS MANAGER CHEMO GROUP Laboratorios Liconsa SA JUNE 2005-JULY 2008 CLINICAL TRIALS COORDINATOR
CRA INVENTFARMA GROUP Laboratorios Lesvi SL NOV 2004 - JUNE 2005 CLINICAL RESEARCH ASSOCIATE INFOCIENCIA CLINICAL RESEARCH AUG 1999 - NOV 2004 AUXILIAR ADMINISTRATIVE INSTITUT CATALÀ DE LA SALUT National Healthcare Service PERIOD TITLE COMPANY JOB DESCRIPTION AND ADQUIRED SKILLS JOB DESCRIPTION ADQUIRED SKILLS Patience Organizational skills Patients reception and customer service.
Phone attention to patients. Administrative support to nurses and physicians.
Facilitate all documentation for patients visits: test records, analytical reports, Medical Histories, etc. Processing mail and phone communications.
Basic tasks of administration and office management.
Daily medical Histories obtention from archive according to the list of Scheduled Visits of the patients. Patients visits recording to medical team agendas.
Computer recording data, texts and other documents.
Internal Informatic System (SIAP) Use. Empathy Asertivity Communicational Skills Work in team Replacement contracts at several outpatient centers primary health care, specialized physicians and Diagnosis Centers Flexibility and puntuality Archiving Administrational Skills Easy to use new tools PERIOD TITLE COMPANY JOB DESCRIPTION AND ADQUIRED SKILLS JOB DESCRIPTION ADQUIRED SKILLS Presenting trial protocols to a steering committee.
Coordinating with the ethics committee.
Managing regulatory authority applications & approvals that oversee the research and marketing of new and existing drugs.
Setting up the trial sites, which includes ensuring each center has the trial materials, including the IMP. Plus training the site staff to trial-specific industry standards. NOV 2004 - JUNE 2005 CLINICAL RESEARCH ASSOCIATE INFOCIENCIA CLINICAL RESEARCH Liaising with doctors/consultants or investigators on conducting the trial; Monitoring the trial, which involves visiting the trial sites on a regular basis.
Source Data Verification: verifying that data entered on to the CRFs is consistent with patient clinical notes.
Collecting completed CRFs from hospitals and general practices.
Writing visit reports.
Filing and collating trial documentation and reports.
Closing down trial sites on completion of the trial Archiving study documentation and correspondence; Planning skills Organizational skills Proactiviveness Resolution Communicational Skills Empathy Assertivity Proactiviveness Proactiviveness Writting skills Archiving and organizational skills Management of designated national and international Clinical Trials carried out in EU & America Planning skills Organizational skills Proactiviveness Resolution Communicational Skills Empathy Assertivity Proactiviveness Proactiviveness Writting skills Archiving and organizational skills Including:
Analysis of potential subjects recruitment
Organising Health Authorities and EC submissions with follow through to ensure successful outcome.
Preparation of trial related documentation
Letters of agreement, confidentiality agreements
Data management plan/ data management report
Statistical Analysis Plan/ statistical report
Analytical protocol/analytical report
Final clinical report PERIOD TITLE COMPANY JOB DESCRIPTION AND ADQUIRED SKILLS JOB DESCRIPTION ADQUIRED SKILLS JUNE 2005-JULY 2008 CLINICAL TRIALS COORDINATOR
CRA INVENT FARMA GROUP Laboratorios Lesvi SL Including Investigator selection, analysis of potential subjects recruitment, preparation of trial related documentation (protocols, CRFs, investigators brochures, consent documents, letters of agreement, confidentiality agreements, data management plan/ data management report, statistical plan/ statistical report, analytical protocol/analytical report and final clinical report), organising Health Authorities and EC submissions with follow through to ensure successful outcome. Communication and Communication in English Skills Flexibility and adaptability to several countries guidelines Analysis skills Writing and Editing skills Monitoring activities and Monitoring Plan Design. Ensuring procedures are in place for appropriate optimization of subjects into the clinical trial including clinical operations. Coordination of movement of laboratory samples and the resulting data when central laboratory facilities are used.
Planning the requirements for clinical trial material
Ordering clinical trial material (head office or local comparators)
Setting up and monitoring the systems to ship CT material to the investigator.
Maintenance of procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary. Liaison with investigators/site personnel in case of inquire about subject inclusion/exclusion criteria Management of subjects recruitment strategies to increase subject inclusion into the trial (eg investigator and research nurse meetings, advertising, letters to GPs).
Review all Aes/ SAEs, ensuring Medical Direction sign-off, that sites are notified and that all company procedures are complied with. Management of third parties. Initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones
Contract with CRO, review periodic status reports, and the interactive management of CRO to ensure project success.
Management and Review of Agreement and insurance policy.
Provide management to the clinical research assistants to ensure that their role and contribution is optimised. Outsourced CRAs supervision, when applicable.
Monitoring of assigned clinical trials following SOPs and in accordance with GCP.
Tracking completed CRFs
Setting up systems whereby completed CRFs are rapidly entered into the database.
Managing of generated queries during cleaning ensuring that are responded to in a timely fashion.
Maintainance of project files (IF&TMF according to ICH guidelines) including:
CVs of investigators and study personnel;
Clinical investigators brochure; protocols;
CRFs instructions; consent documents; clinical trial material shipping orders;
start-up meeting attendance documentation; letters of agreement;
lab reference ranges;
all investigator and site correspondence;
agreements and schedules of payment. Departmental planning sessions, and SOP development. Investigator’s start-up meeting organization and study site initiation meetings. Planning and organizational Skills Efective presentations Skills Selfconfidence and Confidently speaking in public Management of designated national and international Clinical Trials carried out in EU & America Monitoring activities and Monitoring Plan Design Attention to detail Listening attentively Speaking effectively Sensitivity Counceling and situations assessment Cooperation Identification of Resources and problems Problem solving Needs definition Working well with others INTERNATIONAL UNIVERSITY STUDY CENTER Ensuring procedures are in place for appropriate optimization of subjects into the clinical trial including clinical operations. Liaison and first contact with investigators/site personnel in case of enquire about subject inclusion/exclusion criteria. Management of subjects recruitment strategies to increase subject inclusion into the trial eg investigator and research nurse meetings, advertising, letters to GPs.
Review all Aes/ SAEs, ensuring Medical Direction sign-off, that sites are notified and that all company procedures are complied with. Liaison with investigators/site personnel in case of inquire about subject inclusion/exclusion criteria Communication Skills and communication in English Analysis skills Attention to detail Communication in English Speaking effectively Problem solving Planning and organizational Skills Management of third parties Meeting deadlines TECHNICAL COURSES INFORMATION AND COMMUNICATION TRAINING CENTER Trainers Training Universidad de Nebrija Presentaciones efectivas – PREZI Dreamsoft Training Services Formación en Búsquedas Bibliográficas Cochrane Desarrollo de la Competencia Comprensión Interpersonal Haysgroup Gestión de las emociones en situación de presión laboral ABAST S. Comunicación Interpersonal Efectiva IL3 Formación en envío de Solicitudes Electrónicas de Ensayos Clínicos a AEMPs y CEICs AEMPS Documentos Fuente De Los Ensayos Clínicos ESAME Fundation CLINICAL TRIALS TRAINING CENTER BIOEQUIVALENCE TRIALS Revision of Bioequivalence Requirements for Modified Release Products EUFEPS 3rd Ega Symposium On Bioequivalence - De Vere Canary Wharf EGA Introduction to Pharmacokinetics For The Non-Specialist PTI Biodisponibilidad y Bioequivalencia LES HEURES QUALITY ASSURANCE AND PHARMACOVIGILANCE TRAINING CENTER Training on European Pharmacovigilance Laws and legislation RPN Auditorías E Inspecciones En Los Estudios Clínicos IL3 Risk Management LES HEURES