Elena Lapeña

Experience

• 

  Microbiology control

  Jun 1998 - Oct 1998

  Pharmacist/Microbiology Team work
• 

  Madrid

  Jun 1998 - Sept 1998

  Community pharmacist
• 

  Private Community Pharmacy

  Nov 1998 - Apr 2001

  Pharmacist
• 

  Dermopharmacy

  Nov 1999 - Dec 1999

  Comercial
• 

  STIEFEL Dermatology Laboratory

  May 2001 - Jan 2002

  Medical Sale Representative
• 

  Community Pharmacist

  Feb 2002 - Jan 2004

  Boots The Chemist

  Relief pharmacistNewcastle area

• 

  MSD

  Jul 2004 - Apr 2005

  Clinical Research Associate

  6 months training period & 4 months training scholarship

• 

  Dynamic Solutions

  Jan 2005 - Jan 2006

  CRA
• 

  Dymanic

  Apr 2005 - Feb 2006

  CRA
• 

  Quintiles S.L.

  Mar 2006 - Apr 2009

  Senior CRA

  Phase III, Study in LNH area; Phase IV, Study in Dialysis & Diabetic CAPD (Med.); Phase III, Study in Diabetic Nephropathy area. Participated in investigator/site selection/Feasibilities; Performed required pre-study activities to avoid delays after initiationPhase III: Ensured appropriate Ethical Committee and Regulatory Agency submission and approvals, having a working knowledge of local regulatory requirements in Spain. Electronic presentation to the Spanish RA via web; Contract management with the sites.Organized Investigator Meeting and assistanceEnsure that all appropriate and required Study Documentation is obtained and filed in properly.Conducted Source Data Verification & performed data review in timely manner. Queries & safety queries. Carry out & document pre-study, initial, monitoring and final study visits, including final disposal of study suppliesSAEs reporting GCPs/SOPs/ICH-BPC/Real Decreto; FDA requirements; Maintains CTMS data base, InnTrax & InFORMant system, People Soft, Informatics system; Electronic CRF (TRIALink & Phase Forward version 4.5 & 4.6) and electronic CRF designed by Quintiles.IVTS: Clinphone & Cenduit. Show less

• 

  TFS Trial Form Support

  May 2009 - Dec 2010

  Senior CRA

  Phase III, Study in Ovarian Cancer area; Phase III, Study in LNH area. Participated in investigator/site selection/Feasibilities; Performed required pre-study activities to avoid delays after initiation; Phase III: Ensured appropriate Ethical Committee and Regulatory Agency submission and approvals, having a working knowledge of local regulatory requirements in Spain. Electronic presentation to the Spanish RA via web.Contract management with the sites.Organized Investigator Meeting and assistanceEnsure that all appropriate and required Study Documentation is obtained and filed in properly.Conducted Source Data Verification & performed data review in timely manner. Queries & safety queries; Carry out & document pre-study, initial, monitoring and final study visits, including final disposal of study suppliesSAEs reporting; GCPs/SOPs/ICH-BPC/Real Decreto; FDA requirements.Maintains CTMS data base, People Soft, Informatics system & eTrack; Electronic CRF (Phase Forward version 4.5 & 4.6); IVTS: RAMOS Show less

• 

  TFS CRO/GlaxoSmithKline

  May 2009 - Dec 2010

  Phase III, Study in LNH area I am TFS enployee renting to GSK Phase III, Study in Ovarian Cancer

  • Senior CRA

    Aug 2009 - Dec 2010

  • Senior CRA

    May 2009 - Dec 2010

  • Senior CRA

    May 2009 - Dec 2010
• 

  UBC

  Jan 2011 - now

  Evaluate contract/ proposal to ensure proper staffing on overall projectWork with Project Managers to ensure studies are adequately staffed.Ensure staff receive adequate training for specific job assignments.Ensure adherence to company policies and/or sponsor’s SOPs.Work with staff and project team to plan and organize site monitoring.Ensure consistency with maintaining monitoring folders.Work closely with staff and project team to resolve monitoring issues.Report and discuss difficult personnel and/or site issues with Director and/or Project Management, as needed for possible resolutions.Work with staff to monitor workloads and make adjustments as neededConduct performance appraisals and annual co-monitoring assessment visits for direct reportsConduct staff interviewsWorking knowledge of all active protocolsAttend applicable study team teleconferences/meetingsAttend investigator meetings and provide support, as neededEnsure monitor visits occur per project scheduleEnsure monitor visit reports and letters are of good quality, completed and submitted per CRO and client SOPOther duties as assigned Show less Assists with project specific training Ensures appropriate CRA visit scheduling per protocol; tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks. Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager. Attends client and project team meetings – assists with preparation, content and leading of meetings as required. Completes Regulatory Binder and Investigational Product reconciliation. Show less

  • Clinical Operations Manager

    Nov 2013 - now

  • CRA Manager

    Nov 2013 - now

  • Lead CRA

    Jan 2012 - Nov 2015

  • Senior CRA

    Jan 2011 - Aug 2012