Lissy Campos

Profesional creativo y entusiasta con más de 17 años de experiencia en Ensayos Clínicos. Amplia una amplia experiencia en StartUp, Feasibility y Regulatory.  años de experiencia como Clinical Trial Coordinator y Clinical Trial Assistant en todas las fases de los ensayos clínicos.
 

Regulatory Specialist II. KCR CRO, S.L.U. Homebased. Madrid. Spain. Jul 2023-current - Review regulatory documentation for submissions to Competent Authority and Ethics Committee created by sponsor or other vendors. Prepare country specific regulatory documents and adapt regulatory submission packages for initial clinical study applications and amendments to Competent Authority and Ethics Committee and submit them via Spanish Portal. Sr Study Start-Up Specialist. ERGOMED PLC. Homebased. Madrid. Spain. Dec 2021-Jul 2023 - Start-Up. Responsible for the quality deliverables at the country level. Country Start-Up Advisor. Global Site ID and Feasibility Support. Local essential documents collector. Investigator contract and budget negotiator. - Regulatory: Submitting packages via Spanish Portal to EC and Spanish Agency for clinical trials and medical devices. Regional Study Coordinator. LabCorp Drug Development. Homebased. Madrid. Spain. May 2021- Aug 2021 - Collaborate with the Global Study Manager for study set up and closure; ordering of study start up supplies. Monitor, track and provide resolution to all local study issues. Sr Clinical Trials Coordinator / Local Safety Officer. ClinTec (an IQVIA Company). Office Based. Madrid. Spain. Feb 2016- Apr 2021 Working under Contract with Merck Sharp & Dohme de España S.A. - Start-Up: Support the Clinical Operation Manager in the execution and oversight of clinical trial country submissions and approvals for assigned protocols. Drug Safety as local officer. Support the Quality Department. Sr Clinical Trial Assistant/ Start-Up Submission Assistant. Quintiles SL. Office Based. Madrid. Spain. Sep 2007- Feb 2016 Working Under Contract with Roche Farma S.A. - Start-Up and Regulatory Assistant (2013-2016): Support the Regulatory the SSU and Regulatory team to perform feasibility, site identification, Submit regulatory documentation to Competent Authority and Ethics Committee. Clinical Trial Assistant: (2009-2013): Provide administrative and clinical trials assistance for designated clinical development teams. Responsible for all administrative tasks and assisting the clinical project team in the trial's start-up, execution, and close-out. Assist in the distribution of study documents to investigators and site staff

Regulatory Specialist II. KCR CRO, S.L.U. Homebased. Madrid. Spain. Jul 2023-current - Review regulatory documentation for submissions to Competent Authority and Ethics Committee created by sponsor or other vendors. Prepare country specific regulatory documents and adapt regulatory submission packages for initial clinical study applications and amendments to Competent Authority and Ethics Committee and submit them via Spanish Portal. Sr Study Start-Up Specialist. ERGOMED PLC. Homebased. Madrid. Spain. Dec 2021-Jul 2023 - Start-Up. Responsible for the quality deliverables at the country level. Country Start-Up Advisor. Global Site ID and Feasibility Support. Local essential documents collector. Investigator contract and budget negotiator. - Regulatory: Submitting packages via Spanish Portal to EC and Spanish Agency for clinical trials and medical devices. Regional Study Coordinator. LabCorp Drug Development. Homebased. Madrid. Spain. May 2021- Aug 2021 - Collaborate with the Global Study Manager for study set up and closure; ordering of study start up supplies. Monitor, track and provide resolution to all local study issues. Sr Clinical Trials Coordinator / Local Safety Officer. ClinTec (an IQVIA Company). Office Based. Madrid. Spain. Feb 2016- Apr 2021 Working under Contract with Merck Sharp & Dohme de España S.A. - Start-Up: Support the Clinical Operation Manager in the execution and oversight of clinical trial country submissions and approvals for assigned protocols. Drug Safety as local officer. Support the Quality Department. Sr Clinical Trial Assistant/ Start-Up Submission Assistant. Quintiles SL. Office Based. Madrid. Spain. Sep 2007- Feb 2016 Working Under Contract with Roche Farma S.A. - Start-Up and Regulatory Assistant (2013-2016): Support the Regulatory the SSU and Regulatory team to perform feasibility, site identification, Submit regulatory documentation to Competent Authority and Ethics Committee. Clinical Trial Assistant: (2009-2013): Provide administrative and clinical trials assistance for designated clinical development teams. Responsible for all administrative tasks and assisting the clinical project team in the trial's start-up, execution, and close-out. Assist in the distribution of study documents to investigators and site staff